ClinicalTrials.gg
Not yet recruitingNCT07774247AB-TCZUpdated Aug 19, 2026

Atezolizumab, Bevacizumab, and Tocilizumab in Advanced Hepatocellular Carcinoma

A Phase 2 interventional study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma (HCC), sponsored by CHA University. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by CHA University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

This is a Phase 2, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab, bevacizumab, and tocilizumab in patients with locally advanced, metastatic, and/or unresectable hepatocellular carcinoma (HCC). Approximately 51 patients will be enrolled at 6 study sites and will receive combination therapy consisting of atezolizumab, bevacizumab, and tocilizumab. Patients assigned to the study will receive atezolizumab 1,200 mg intravenously and bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle, alongside tocilizumab 4 mg/kg intravenously on Day 1 of each 42-day cycle for up to 5 doses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The study population includes adult patients with locally advanced, metastatic, and/or unresectable HCC who have received no prior systemic therapy for hepatocellular carcinoma. Eligible patients must have histologically, cytologically, or radiologically confirmed diagnosis, at least one measurable lesion according to RECIST version 1.1, Child-Pugh class A liver function, ECOG performance status 0 or 1, and adequate organ function. The primary objective is to assess the incidence of Grade 3 or higher immune-related adverse events (irAEs) occurring within 24 weeks after treatment initiation according to NCI CTCAE version 5.0. Secondary objectives include evaluation of objective response rate (ORR) and disease control rate (DCR) according to RECIST v1.1, progression-free survival, overall survival, and the rate of treatment discontinuation due to adverse events. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of the correlation between treatment response and serum inflammatory markers (such as IL-6 and CRP) and immune cell profiles using blood samples collected at protocol-defined intervals. Tumor assessments will be performed at protocol-defined intervals using radiologic imaging every 6 weeks from Cycle 1 Day 1 up to Week 54, and every 9 weeks thereafter. The primary efficacy analysis will be based on the Full Analysis Set according to RECIST v1.1. This study is intended to evaluate the clinical activity and safety profile of prophylactic tocilizumab in combination with atezolizumab and bevacizumab in this patient population and to generate data to inform future clinical development.

02

Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • HCC
  • IL-6
  • Immunotherapy
  • Tocilizumab
03

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 51 is close to the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histologically, cytologically, or radiologically confirmed diagnosis of locally advanced, , and/or unresectable hepatocellular carcinoma (HCC).
  2. Age ≥19 years at the time of signing the form (ICF).
  3. (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study drug.
  4. class A (score 5-6) within 7 days prior to the first dose of study drug.
  5. Disease not amenable to curative surgical and/or locoregional therapy.

    - Patients who have experienced disease progression after prior surgical and/or locoregional therapy are eligible.

  6. Ability to provide written informed consent prior to initiation of any study-specific procedures, including agreement to comply with the requirements and restrictions listed in this protocol.
  7. No prior systemic therapy for hepatocellular carcinoma, including agents.

    - Prior use of herbal or traditional medicines with known or potential anticancer activity is permitted only if discontinued prior to initiation of study treatment.

  8. Estimated of at least 3 months.
  9. At least one according to version 1.1.

    - Patients who have received prior locoregional therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, or transarterial embolization) are eligible if the target lesion has not been previously treated or if the lesion has demonstrated progression within the treated area per RECIST v1.1.

  10. Adequate hematologic and organ function, as defined by the following laboratory values obtained within 7 days prior to the first dose of study drug (no blood transfusion or albumin administration within 2 weeks prior to or during screening to meet eligibility criteria).

    • (ANC) ≥ 1.5 x 109/L (≥1500/μL)
    • Lymphocyte count ≥ 0.5 x 109/L (≥500/μL)
    • count ≥ 100 x 109/L (≥100,000/μL)
    • ≥ 90 g/L (≥9.0 g/dL)
    • , ALT, and ALP ≤ 5 x
    • Total ≤ 3 x ULN
    • Serum creatinine ≤ 1.5 x ULN or ≥50 mL/min (calculated using the Cockcroft-Gault formula)
    • Albumin ≥ 28 g/L (≥2.8 g/dL)
    • For patients not receiving anticoagulants: or aPTT ≤1.5 x ULN, patients receiving low-molecular-weight heparin are eligible.
  11. Documented hepatitis virus status based on screening tests for and .

    • For patients with active HBV infection: HBV DNA \<500 IU/mL during screening, initiation of antiviral therapy at least 14 days prior to the first dose of study drug, and willingness to continue antiviral therapy throughout the study.
    • For patients with active or prior HCV infection: negative HCV RNA (PCR).
    • Patients with co-infection of HBV and HCV are not eligible.
  12. Reproductive status:

    • Female patients must not be pregnant or breastfeeding.
    • Negative serum pregnancy test within 72 hours prior to the first dose of study drug.
    • Female patients must agree not to breastfeed from the time of consent until at least 6 months after the last dose of study drug.
    • Females of and non-sterilized males must agree to use two effective methods of during the study and for at least 6 months after the last dose.
  13. (LVEF) ≥50% as assessed by echocardiogram or MUGA scan, with no severe valvular disease or arrhythmia.
  14. interval using Fridericia's formula (QTcF) ≤470 msec.
  15. Willingness to provide blood samples.

Exclusion criteria

Exclusion Criteria:

  1. Prior systemic therapy for locally advanced, , and/or unresectable hepatocellular carcinoma, including chemotherapy, biologic therapy, immunotherapy, hormonal therapy, or agents.

    - Prior therapy is permitted if disease recurrence occurred at least 6 months after completion of the last treatment, including adjuvant therapy and radiotherapy.

  2. Presence of multiple primary .

    - Exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or other malignancies with no recurrence for ≥5 years.

  3. Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma.
  4. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding: Patients must undergo esophagogastroduodenoscopy (EGD) prior to enrollment, and all varices must be evaluated and treated according to institutional standard of care. If evaluation has been performed within 6 months prior to the first dose of study drug, repeat evaluation is not required.
  5. Residual toxicities from prior therapy that, in the investigator's opinion, may interfere with safety evaluation of the study drug, or patients for whom the possibility of surgical resection cannot be completely excluded at the time of enrollment.
  6. History of severe reactions to other monoclonal antibody products.

    • Prior exposure to or hypersensitivity to , anti-PD-L1, anti-PD-L2, anti-CD137 antibodies, or other agents targeting T-cell regulation.
    • Known hypersensitivity or allergy to atezolizumab, bevacizumab, or tocilizumab.
  7. Active disease or a history of chronic or recurrent autoimmune disease, or use of systemic medications within 2 weeks prior to the first dose of study drug.

    • Patients with hypothyroidism requiring only hormone replacement therapy, vitiligo, psoriasis not requiring systemic treatment, or other conditions deemed stable and safe by the investigator may be eligible.
    • Patients with primary or secondary immunodeficiency or active immunodeficiency are excluded.
  8. Current or prior history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings.

    - Patients with radiation pneumonitis may be eligible if clinically stable (beyond the acute phase) without concern for recurrence.

  9. Known central nervous system (CNS) metastases.
  10. Presence of pericardial effusion, pleural effusion, or ascites requiring treatment.
  11. Uncontrolled tumor-related pain: patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control during study treatment are excluded.
  12. History of or cerebrovascular accident within 180 days prior to enrollment.
  13. History of significant cardiovascular disease, including any of the following:

    • Myocardial infarction within 180 days prior to enrollment.
    • Uncontrolled angina within 180 days prior to enrollment
    • Congestive heart failure classified as (NYHA) Class III or IV.
    • Uncontrolled hypertension despite appropriate medical management (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg persisting for ≥24 hours).
    • Arrhythmia requiring treatment.
    • Significant vascular disease, including recent peripheral arterial thrombosis or aneurysm requiring surgical intervention.
  14. Uncontrolled diabetes mellitus.
  15. Systemic infection requiring treatment within 14 days prior to the first dose of study drug and treated with intravenous antibiotics (prophylactic use of oral antibiotics is permitted).
  16. Use of systemic (>10 mg/day of prednisolone or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study drug (excluding short-term use for diagnostic, prophylactic, or similar purposes).
  17. Patients who received anticancer therapy (e.g., cytotoxic chemotherapy, targeted therapy, immunotherapy) within 28 days prior to the first dose of study drug.

    - Adjuvant therapy completed more than 6 months prior is permitted.

  18. Pleurodesis or pericardiodesis within 28 days prior to the first dose of study drug.
  19. Current or recent (within 2 weeks) use of aspirin (>325 mg/day) or antiplatelet agents such as clopidogrel, dipyridamole, ticlopidine, or cilostazol for therapeutic purposes: prophylactic anticoagulation is permitted if \<1.5 × and aPTT is within normal limits.
  20. Major surgery under general anesthesia within 28 days prior to the first dose of study drug.
  21. Surgery under local anesthesia within 14 days prior to the first dose of study drug.
  22. Palliative radiotherapy within 28 days prior to the first dose of study drug, or radiotherapy to bone metastases within 14 days prior to the first dose.
  23. Positive test for any of the following:

    - -1 antibody, HIV-2 antibody.

  24. Pregnant or breastfeeding patients, or those with a possibility of pregnancy or plans to become pregnant.
  25. Patients who received unapproved or investigational agents (e.g., investigational drugs, unapproved drug combinations, or unapproved formulations) within 28 days prior to enrollment.
  26. Patients deemed unable to provide due to comorbid conditions such as dementia.
  27. Patients unable or unwilling to sign the informed consent form.
  28. Known pre-existing central nervous system demyelinating disorders or seizure disorders.
  29. Known active diverticulitis, chronic ulcerative lower gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis), or other symptomatic lower gastrointestinal conditions that may predispose patients to gastrointestinal perforation.
  30. Current active infection or history of recurrent infections, including but not limited to tuberculosis, atypical mycobacterial infection, herpes zoster, or other bacterial, viral, fungal, or mycobacterial infections (excluding fungal nail bed infections).
Terms in these criteria, in plain language(33)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Atezolizumab + Bevacizumab + Tocilizumab

    Patients will receive atezolizumab 1,200 mg intravenously on Day 1 of each 21-day cycle and bevacizumab 15 mg/kg intravenously on Day 1 of each 21-day cycle, administered until disease progression, unacceptable toxicity, or a maximum duration of 2 years. In addition, patients will receive prophylactic tocilizumab 4 mg/kg intravenously on Day 1 of each 42-day cycle (every 6 weeks) for up to a maximum of 5 doses.

    Drug: Atezolizumab · Drug: Bevacizumab · Drug: Tocilizumab

Interventions

  • Atezolizumab will be administered intravenously at a fixed dose of 1,200 mg on Day 1 of each 21-day cycle. The initial infusion will be administered over 60 (±5) minutes. Subsequent infusions may be administered over 30 (±5) minutes if well tolerated, or 60 (±5) minutes if infusion-related reactions occurred previously.

  • Bevacizumab will be administered intravenously at a dose of 15 mg/kg on Day 1 of each 21-day cycle. The initial infusion will be administered over 90 (±5) minutes. If well tolerated, the second infusion may be administered over 60 (±5) minutes, and subsequent infusions over 30 (±5) minutes. Bevacizumab must be administered at least 5 minutes after completion of atezolizumab infusion. Bevacizumab should be administered ≥3 days after biopsy and only after adequate wound healing is confirmed.

  • Tocilizumab will be administered intravenously at a dose of 4 mg/kg over at least 60 minutes on Day 1 of each 42-day cycle, for up to 5 doses. On C1D1, tocilizumab will be administered at least 60 minutes after completion of bevacizumab infusion. In subsequent cycles, if the previous bevacizumab infusion was well tolerated without premedication, tocilizumab may be administered ≥30 minutes after bevacizumab. If infusion-related reactions occurred, tocilizumab must be administered ≥60 minutes after bevacizumab.

06

What researchers measure

Primary outcomes

  1. Incidence of grade ≥3 immune-related adverse events (irAEs) within 24 weeks after treatment initiation

    Incidence of Grade 3 or higher immune-related adverse events (irAEs) occurring after treatment initiation, evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Time frame: Within 24 weeks after treatment initiation.

Secondary outcomes

  1. Objective Response Rate (ORR) by Investigator According to RECIST v1.1

    ORR is defined as the proportion of participants with a best overall response of CR or PR, as assessed by the investigator according to RECIST v1.1.

    Time frame: From baseline (Cycle 1 Day 1) until disease progression or end of treatment, assessed every 6 weeks through Week 54 and every 9 weeks thereafter, up to 2 years.

  2. Disease Control Rate (DCR) by Investigator According to RECIST v1.1

    DCR is defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), as assessed by the investigator according to RECIST v1.1.

    Time frame: From baseline (Cycle 1 Day 1) until disease progression or end of treatment, assessed every 6 weeks through Week 54 and every 9 weeks thereafter, up to 2 years

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of study treatment to the date of first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

    Time frame: From the first dose of study treatment until first documented disease progression or death from any cause, up to approximately 36 months

  4. Overall Survival (OS)

    OS is defined as the time from the first dose of study treatment to the date of death from any cause.

    Time frame: From the first dose of study treatment up to the end of study follow-up (up to approximately 36 months)

  5. Rate of Treatment Discontinuation Due to Adverse Events

    The proportion of participants who permanently discontinue study treatment (atezolizumab, bevacizumab, and/or tocilizumab) due to treatment-related adverse events.

    Time frame: From the first dose until 28 days after the last dose of study treatment (up to approximately 2 years)

Other outcomes

  1. Correlation Between Treatment Response and Serum Inflammatory Markers and Immune Cell Profiles

    Evaluation of the correlation between clinical response (and safety outcomes) and changes in serum inflammatory markers (including interleukin-6 \[IL-6\] and C-reactive protein \[CRP\]) as well as immune cell profiling from peripheral blood mononuclear cells (PBMCs) and other exploratory biomarkers (e.g., ctDNA, RNA sequencing).

    Time frame: Blood samples will be collected prior to the first dose of study drug (baseline), at 3 weeks, 6 weeks, 6 months, 1 year, and 2 years after treatment initiation, and at the time of disease progression (up to approximately 2 years).

07

Study locations

1 site
08

References and documents

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PubMed 30207593 ↗
  • Singal AG, Llovet JM, Yarchoan M, Mehta N, Heimbach JK, Dawson LA, Jou JH, Kulik LM, Agopian VG, Marrero JA, Mendiratta-Lala M, Brown DB, Rilling WS, Goyal L, Wei AC, Taddei TH. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023 Dec 1;78(6):1922-1965. doi: 10.1097/HEP.0000000000000466. Epub 2023 May 22. No abstract available. PubMed 37199193 ↗
  • Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3. PubMed 33479224 ↗
  • Lazzaro A, Hartshorn KL. A Comprehensive Narrative Review on the History, Current Landscape, and Future Directions of Hepatocellular Carcinoma (HCC) Systemic Therapy. Cancers (Basel). 2023 Apr 27;15(9):2506. doi: 10.3390/cancers15092506. PubMed 37173972 ↗
  • Senthilnathan S, Memon K, Lewandowski RJ, Kulik L, Mulcahy MF, Riaz A, Miller FH, Yaghmai V, Nikolaidis P, Wang E, Baker T, Abecassis M, Benson AB 3rd, Omary RA, Salem R. Extrahepatic metastases occur in a minority of hepatocellular carcinoma patients treated with locoregional therapies: analyzing patterns of progression in 285 patients. Hepatology. 2012 May;55(5):1432-42. doi: 10.1002/hep.24812. Epub 2012 Apr 4. PubMed 22109811 ↗
  • Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745. PubMed 32402160 ↗
  • Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, Sukeepaisarnjaroen W, Kang YK, Van Dao T, De Toni EN, Rimassa L, Breder V, Vasilyev A, Heurgue A, Tam VC, Mody K, Thungappa SC, Ostapenko Y, Yau T, Azevedo S, Varela M, Cheng AL, Qin S, Galle PR, Ali S, Marcovitz M, Makowsky M, He P, Kurland JF, Negro A, Sangro B. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070. doi: 10.1056/EVIDoa2100070. Epub 2022 Jun 6. PubMed 38319892 ↗
  • Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Pena AM, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M; CheckMate 9DW investigators. Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial. Lancet. 2025 May 24;405(10492):1851-1864. doi: 10.1016/S0140-6736(25)00403-9. Epub 2025 May 8. PubMed 40349714 ↗
  • Tian JC, Liu H, Yan LJ, Ding ZN, Han CL, Tian BW, Tan SY, Dong ZR, Wang DX, Xue JS, Mao XC, Yan YC, Li T. Adverse events of immune checkpoint inhibitors in hepatocellular carcinoma: a systemic review and meta-analysis. Clin Exp Med. 2023 Oct;23(6):2115-2129. doi: 10.1007/s10238-022-00938-6. Epub 2022 Nov 16. PubMed 36385419 ↗
  • Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10. PubMed 26970723 ↗
  • Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4. PubMed 26952546 ↗
  • Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25. PubMed 14745444 ↗
  • Chan LL, Kwong TT, Yau JCW, Chan SL. Treatment for hepatocellular carcinoma after immunotherapy. Ann Hepatol. 2025 Jul-Dec;30(2):101781. doi: 10.1016/j.aohep.2025.101781. Epub 2025 Feb 8. PubMed 39929474 ↗
  • Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbe C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11. PubMed 28889792 ↗
  • Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27. PubMed 30811280 ↗
  • Hailemichael Y, Johnson DH, Abdel-Wahab N, Foo WC, Bentebibel SE, Daher M, Haymaker C, Wani K, Saberian C, Ogata D, Kim ST, Nurieva R, Lazar AJ, Abu-Sbeih H, Fa'ak F, Mathew A, Wang Y, Falohun A, Trinh V, Zobniw C, Spillson C, Burks JK, Awiwi M, Elsayes K, Soto LS, Melendez BD, Davies MA, Wargo J, Curry J, Yee C, Lizee G, Singh S, Sharma P, Allison JP, Hwu P, Ekmekcioglu S, Diab A. Interleukin-6 blockade abrogates immunotherapy toxicity and promotes tumor immunity. Cancer Cell. 2022 May 9;40(5):509-523.e6. doi: 10.1016/j.ccell.2022.04.004. Epub 2022 May 9. PubMed 35537412 ↗
  • Campochiaro C, Farina N, Tomelleri A, Ferrara R, Lazzari C, De Luca G, Bulotta A, Signorelli D, Palmisano A, Vignale D, Peretto G, Sala S, Esposito A, Garassino M, Gregorc V, Dagna L. Tocilizumab for the treatment of immune-related adverse events: a systematic literature review and a multicentre case series. Eur J Intern Med. 2021 Nov;93:87-94. doi: 10.1016/j.ejim.2021.07.016. Epub 2021 Aug 12. PubMed 34391591 ↗
  • Petit PF, Daoudlarian D, Latifyan S, Bouchaab H, Mederos N, Doms J, Abdelhamid K, Ferahta N, Mencarelli L, Joo V, Bartolini R, Stravodimou A, Shabafrouz K, Pantaleo G, Peters S, Obeid M. Tocilizumab provides dual benefits in treating immune checkpoint inhibitor-associated arthritis and preventing relapse during ICI rechallenge: the TAPIR study. Ann Oncol. 2025 Jan;36(1):43-53. doi: 10.1016/j.annonc.2024.08.2340. Epub 2024 Sep 5. PubMed 39241964 ↗
  • Roulleaux Dugage M, Lambotte O, Mariette X, Marabelle A. Breaking the link: IL-6 targeting to uncouple toxicity and efficacy in patients treated with immune checkpoint blockade. Ann Oncol. 2025 Jan;36(1):6-9. doi: 10.1016/j.annonc.2024.09.007. Epub 2024 Nov 26. No abstract available. PubMed 39755430 ↗
  • Yang H, Kang B, Ha Y, Lee SH, Kim I, Kim H, Lee WS, Kim G, Jung S, Rha SY, Gaillard VE, Cheon J, Kim C, Chon HJ. High serum IL-6 correlates with reduced clinical benefit of atezolizumab and bevacizumab in unresectable hepatocellular carcinoma. JHEP Rep. 2023 Jan 16;5(4):100672. doi: 10.1016/j.jhepr.2023.100672. eCollection 2023 Apr. PubMed 36866388 ↗
  • Myojin Y, Kodama T, Sakamori R, Maesaka K, Matsumae T, Sawai Y, Imai Y, Ohkawa K, Miyazaki M, Tanaka S, Mita E, Tawara S, Yakushijin T, Nozaki Y, Hagiwara H, Tahata Y, Yamada R, Hikita H, Tatsumi T, Takehara T. Interleukin-6 Is a Circulating Prognostic Biomarker for Hepatocellular Carcinoma Patients Treated with Combined Immunotherapy. Cancers (Basel). 2022 Feb 10;14(4):883. doi: 10.3390/cancers14040883. PubMed 35205631 ↗
  • Miura R, Ono A, Nakahara H, Shirane Y, Yamaoka K, Fujii Y, Uchikawa S, Fujino H, Murakami E, Kawaoka T, Miki D, Tsuge M, Kishi T, Ohishi W, Sakamoto N, Arihiro K, Hayes CN, Oka S. Serum IL-6 concentration is a useful biomarker to predict the efficacy of atezolizumab plus bevacizumab in patients with hepatocellular carcinoma. J Gastroenterol. 2025 Mar;60(3):328-339. doi: 10.1007/s00535-024-02185-w. Epub 2024 Dec 9. PubMed 39652104 ↗
  • Liu H, Shen J, Lu K. IL-6 and PD-L1 blockade combination inhibits hepatocellular carcinoma cancer development in mouse model. Biochem Biophys Res Commun. 2017 Apr 29;486(2):239-244. doi: 10.1016/j.bbrc.2017.02.128. Epub 2017 Mar 1. PubMed 28254435 ↗
  • Zhou TY, Zhou YL, Qian MJ, Fang YZ, Ye S, Xin WX, Yang XC, Wu HH. Interleukin-6 induced by YAP in hepatocellular carcinoma cells recruits tumor-associated macrophages. J Pharmacol Sci. 2018 Oct;138(2):89-95. doi: 10.1016/j.jphs.2018.07.013. Epub 2018 Sep 22. PubMed 30340922 ↗
  • Drakaki A, Powles T, Bamias A, Martin-Liberal J, Shin SJ, Friedlander T, Tosi D, Park C, Gomez-Roca C, Joly Lobbedez F, Castellano D, Morales-Barrera R, Moreno-Candilejo I, Flechon A, Yuen K, Rishipathak D, DuPree K, Young F, Michielin F, Shemesh CS, Steinberg EE, Williams P, Lee JL. Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma). Clin Cancer Res. 2023 Nov 1;29(21):4373-4384. doi: 10.1158/1078-0432.CCR-23-0798. PubMed 37651261 ↗
  • Webb LM, Okuno SH, Ransom RC, Van Gompel JJ, Humes AL, Sarkaria JN, Ruff MW. Recurrent adamantinomatous craniopharyngioma stabilized with tocilizumab and bevacizumab: illustrative case. J Neurosurg Case Lessons. 2025 Jan 13;9(2):CASE24410. doi: 10.3171/CASE24410. Print 2025 Jan 13. PubMed 39805108 ↗
  • Lau G, Sangro B, Cheng AL, Kudo M, Kelley RK, Tak WY, Gasbarrini A, Reig M, Lim HY, Tougeron D, De Toni EN, Tam VC, Mody K, Gong J, Crysler OV, Sukeepaisarnjaroen W, Lipatov O, Morimoto M, Archambeaud I, Burgio V, Phuong LTT, Chao Y, Peron JM, Berres ML, Ko YJ, Ran D, Makowsky M, Negro A, Abou-Alfa GK. Immune-mediated adverse events and overall survival with tremelimumab plus durvalumab and durvalumab monotherapy in unresectable HCC: HIMALAYA phase III randomized clinical trial. Hepatology. 2026 Mar 1;83(3):484-496. doi: 10.1097/HEP.0000000000001385. Epub 2025 May 16. PubMed 40384092 ↗
  • Nam H, Lee J, Han JW, Lee SK, Yang H, Lee HL, Sung PS, Kim HY, Kim SH, Song MJ, Kwon JH, Kim CW, Nam SW, Bae SH, Choi JY, Yoon SK, Jang JW. Analysis of Immune-Related Adverse Events of Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma: A Multicentre Cohort Study. Liver Cancer. 2023 Dec 21;13(4):413-425. doi: 10.1159/000535839. eCollection 2024 Aug. PubMed 39114756 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 348 non-industry phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 78. This study's planned 12 months is below that.

Counting every sponsor, half of 428 studies reached it within 43 months; a quarter within 30 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 19, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 1, 2029
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07774247
Lead sponsor
CHA University
Responsible party
Hong Jae Chon (Principal Investigator, CHA University) — Principal investigator
First posted
Aug 19, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Aug 19, 2026

Study contacts

Hong Jae Chon, MD. PhD
Contact
hongjaechon@gmail.com
+82-31-780-3928

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Bevacizumab · Tocilizumab

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