An interventional study of TACE-HAIC + Atezolizumab + Low-dose Bevacizumab in Hepatocellular Carcinoma, Atezolizumab Plus Bevacizumab and Transarterial Chemoembolization, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy.
Although atezolizumab plus bevacizumab has become a standard first-line treatment option for advanced HCC, the objective response rate remains limited. TACE-HAIC may improve tumor control by increasing local chemotherapy exposure, promoting tumor antigen release, and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. In this study, patients will receive TACE-HAIC in combination with atezolizumab and low-dose bevacizumab, followed by maintenance treatment with atezolizumab plus low-dose bevacizumab until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints include ORR by mRECIST, disease control rate, duration of response, progression-free survival, time to progression, overall survival, and safety. This study aims to explore whether this combination strategy can provide improved anti-tumor activity with manageable safety in patients with unresectable HCC.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 38 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Voluntarily provides written . Age ≥18 years. or cytologically confirmed hepatocellular carcinoma (HCC), or clinically diagnosed HCC in patients with cirrhosis according to AASLD criteria.
Unresectable HCC suitable for TACE treatment, including BCLC stage B or C, without Vp4 portal vein tumor thrombus or extrahepatic .
No prior systemic therapy for HCC. (ECOG) performance status of 0 or 1. class A or class B7 liver function. No history of disease. of at least 3 months. At least one according to v1.1.
Adequate hematologic, hepatic, and renal function within 1 week before enrollment:
Neutrophils ≥1.5 × 10\^9/L ≥50 × 10\^9/L ≥90 g/L and AST ≤5 × (ULN) Serum creatinine ≤1.5 × ULN \<2.3, or prothrombin time ≤ULN + 6 seconds Albumin ≥30 g/L Total ≤3 × ULN Women of must have a negative serum or urine pregnancy test within 7 days before enrollment, must not be breastfeeding, and must agree to use effective during the study and for 6 months after the end of study treatment. Men must also agree to use effective contraception during the study and for 6 months after the end of study treatment.
Exclusion Criteria:
Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; or other active within 5 years, except adequately treated localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
Severe allergy to iodinated contrast agents that precludes TACE-HAIC treatment. Use of agents or systemic for immunosuppressive purposes within 1 month before enrollment.
Active infection that cannot be effectively controlled. Severe gastroesophageal varices, or untreated/incompletely treated varices with bleeding or high bleeding risk.
or bone requiring urgent surgical or radiotherapeutic intervention.
Pregnancy, suspected pregnancy, or breastfeeding. Current use of, or recent use within 10 days before study treatment of, aspirin >325 mg/day, dipyridamole, ticlopidine, clopidogrel, or cilostazol.
Thrombotic or embolic events within 6 months before treatment initiation, including cerebrovascular accident, , cerebral hemorrhage, cerebral infarction, or pulmonary embolism.
Congenital or acquired immunodeficiency. Any of the following within 12 months before study start: myocardial infarction, severe or unstable angina, or congestive heart failure.
Renal failure requiring dialysis. Prior organ transplantation. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality, that may increase study risk, interfere with interpretation of results, or make the patient unsuitable for enrollment in the investigator's judgment.
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.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with unresectable hepatocellular carcinoma who have not received prior systemic therapy will be enrolled into a single treatment cohort. All participants will receive transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) in combination with atezolizumab and low-dose bevacizumab as first-line treatment. Atezolizumab will be administered at a fixed dose of 1200 mg intravenously every 3 weeks, and bevacizumab will be administered at 7.5 mg/kg intravenously every 3 weeks. HAIC will be given using the FOLFOX regimen, and subsequent TACE will be performed as needed according to the patient's condition and investigator judgment. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria.
Drug: TACE-HAIC + Atezolizumab + Low-dose Bevacizumab
Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen, administered via hepatic artery catheter. The HAIC regimen consists of oxaliplatin 85 mg/m² by arterial infusion over 2 hours on Day 1, followed by leucovorin 400 mg/m² by arterial infusion over 1 hour on Day 1, then fluorouracil 400 mg/m² bolus infusion and 2400 mg/m² continuous infusion over 24 hours. Subsequently, participants receive intravenous atezolizumab (1200 mg fixed dose, every 3 weeks) and low-dose bevacizumab (7.5 mg/kg, every 3 weeks). Each treatment cycle is 21 days. Treatment continues until disease progression according to RECIST v1.1, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria.
This study also gives Atezolizumab. No intervention listed here names it: that was found by reading the record.
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
Time frame: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atezolizumab
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