ClinicalTrials.gg
RecruitingNCT06954116CCGLC-017Updated Sep 18, 2026

Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence

A Phase 2 interventional study of Iparomlimab and Tuvonralimab (QL1706) and Partial hepatectomy in Resectable Hepatocellular Carcinoma With High Risk of Recurrence, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Tongji Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular — 13 open to participants now, 13 under way, 1 of them phase 3. Iparomlimab/Tuvonralimab · Carcinoma, Hepatocellular.

Planned enrollment
10th of 13
26 · median 35
Started
2025
with 8 others
Phase 2
7 of 13
7 open now
Primary completion
2028-12
later than 10 of 12 live
Registered
5th of 13
by date
Lead sponsor
1 of 13
Tongji Hospital

Among the 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular, this one is the 10th largest by planned enrollment, is one of 9 that started in 2025, is one of 7 in phase 2, reaches primary completion later than 10 of the 12 other live ones, and was the 5th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

13 of the 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Where they have run

About Iparomlimab/Tuvonralimab

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.

Read the detailed description

CCGLC-017 is a prospective, open-label, single-arm, exploratory clinical study. This study primarily evaluates the impact of iparomlimab and tuvonralimab (QL1706) as preoperative neoadjuvant therapy on recurrence-free survival (RFS), with exploratory analysis of its potential benefits on overall survival (OS) in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence. Enrolled patients will receive a single dose of iparomlimab and tuvonralimab within one week prior to surgery, followed by six cycles of iparomlimab and tuvonralimab therapy postoperatively.

03

Conditions studied

  • Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Keywords

  • Hepatocellular Carcinoma
  • Neoadjuvant Therapy
  • Iparomlimab and Tuvonralimab
  • Immunotherapy
  • Anti-recurrence
04

Who can participate

Ages eligible
18 Years to 75 Years
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

  • Hepatocellular carcinoma is proven on or confirmed by the presence of radiological hallmarks, according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines.
  • Aged 18 to 75 years.
  • BCLC A/B, or BCLC C without extrahepatic .
  • Suitable for radical surgery after evaluation by the hepatobiliary tumor MDT expert group.
  • No distant metastasis confirmed by CT or MRI.
  • No prior systemic anti-tumor treatment for hepatocellular carcinoma before the first dose.
  • ≤ 2.
  • ≤ 7.
  • Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests):

    1. Complete blood count: (ANC) ≥1.5×10\^9/L; count (PLT) ≥75×10\^9/L; (HGB) ≥9.0 g/dL.
    2. Liver function: Total (TBIL) ≤2× Value (ULN); (ALT) and Aspartate Transferase (AST) ≤5×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN.

C. Kidney function: Serum Creatinine (Cr) ≤ 1.5×ULN or Clearance of Creatinine (CCr) ≥50mL/min ( formula); Urinalysis shows proteinuria \<2+; For subjects with baseline urinalysis showing proteinuria ≥2+, a 24-hour urine collection should be performed and 24-hour urinary protein quantification \<1g.

D. Coagulation function: (INR) ≤2.3 or Prothrombin Time (PT) extension ≤6 seconds.

  • Meet the criteria for resectable HCC with High Risk of Recurrence:

    1. Multiple (≥2) tumors.
    2. Segmental portal vein invasion (Vp1/Vp2).
    3. CT/MRI imaging: gross classification: type II, III, IV.
  • Estimated of ≥12 weeks.
  • Female subjects of childbearing age or male subjects whose sexual partners are of childbearing age need to take effective measures during the entire treatment period and for 6 months after the last medication.
  • Signed written , and able to comply with the visit and related procedures stipulated in the protocol.

Exclusion criteria

Exclusion Criteria:

  • Histologically/ confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
  • History of hepatic encephalopathy or liver transplantation.
  • Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Subjects with only radiologically detected minimal pleural effusion, ascites, or pericardial effusion without symptoms can be enrolled.
  • Acute or chronic active or C infection, with hepatitis B virus (HBV) DNA >2000IU/ml or 10\^4 copies/ml; virus (HCV) RNA >10\^3 copies/ml; co-positive for hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Subjects who meet the above criteria after antiviral treatment with nucleoside analogs can be enrolled.
  • History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months. Subjects assessed by the investigator to be at high risk of bleeding.
  • Any life-threatening bleeding event within the past 3 months, including those requiring blood transfusion, surgery or local treatment, or continuous drug treatment.
  • History or current diagnosis of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
  • Active pulmonary tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.
  • Active disease requiring systemic treatment (such as disease-modifying drugs, , or ) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is allowed. History of primary immunodeficiency. Patients with only autoantibody positivity need to be confirmed by the investigator whether there is an autoimmune disease.
  • History of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or , pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic events. Exceptions are made for thrombosis formation related to implanted venous infusion ports or catheters, or superficial vein thrombosis that has stabilized after routine anticoagulation treatment. Preventive use of low-dose low molecular weight heparin (such as enoxaparin 40 mg/day) is allowed.
  • Continuous use of aspirin (>325 mg/day) or other known function inhibitors such as clopidogrel or ticlopidine for 10 days within 2 weeks prior to the first dose.
  • Uncontrolled hypertension, with systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
  • Major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose. Minor surgical procedures or tissue within 7 days prior to the first dose, excluding venous puncture for the purpose of intravenous infusion, are excluded.
  • Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival evaluation, or other conditions judged by the investigator to be unsuitable for enrollment.
  • History of gastrointestinal perforation and/or fistula within the previous 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.
Terms in these criteria, in plain language(22)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

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

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

05

Study design

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

Study arms

  • Experimental
    Experimental: Iparomlimab and Tuvonralimab

    Patients will receive a single preoperative dose of Iparomlimab and Tuvonralimab (7.5 mg/kg) within one week prior to surgery. Partial hepatectomy will be performed at an appropriate interval following neoadjuvant therapy initiation. From the second week postoperatively, adjuvant therapy with six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be administered.

    Drug: Iparomlimab and Tuvonralimab (QL1706) · Procedure: Partial hepatectomy

Interventions

  • DrugIparomlimab and Tuvonralimab (QL1706)

    Drug page: Iparomlimab/Tuvonralimab

    Neoadjuvant phase: A single cycle of Iparomlimab and Tuvonralimab (7.5 mg/kg) will be administered within 1 week prior to surgery. Adjuvant phase: Six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be initiated starting at 2 weeks postoperatively.

  • ProcedurePartial hepatectomy

    Will be performed at an appropriate interval following neoadjuvant therapy initiation.

06

What researchers measure

Primary outcomes

  1. Recurrence-Free Survival (RFS)

    The duration will be calculated from the date of achieving complete response (CR) after surgery to the first documented occurrence of intrahepatic or extrahepatic HCC recurrence, or death from any cause, whichever comes first.

    Time frame: From the date of achieving complete response (CR) after surgery until the date of first documented recurrence or death from any cause, assessed up to 24 months post-surgery.

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival (OS): measured from date of first treatment to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last visit.

    Time frame: from the date of first treatment to the date of death from any cause, assessed up to 5 years

  2. Major Pathological Response (MPR)

    Defined as the presence of ≤50% residual viable tumor cells in the resected specimen confirmed by postoperative pathological examination.

    Time frame: Intraoperative frozen section assessment and final postoperative pathology (assessed within 4 weeks after surgery).

  3. Investigator-Assessed Recurrence-Free Survival (RFS)

    Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence, or death from any cause (whichever occurs first), as determined by the investigator.

    Time frame: From treatment initiation until the date of first documented HCC recurrence or death from any cause, whichever occurs first, assessed up to 24 months.

  4. Time to Recurrence (TTR)

    Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence event.

    Time frame: From treatment initiation until the date of first documented HCC recurrence, assessed up to 24 months.

  5. IRF-Assessed RFS Rate at 12 and 24 Months

    Defined as the proportion of patients without documented intrahepatic/extrahepatic HCC recurrence or death from any cause at 12 and 24 months post-treatment, assessed by an independent review facility (IRF) using standardized imaging criteria (RECIST 1.1/mRECIST).

    Time frame: At 12 and 24 months post-treatment.

  6. Investigator-Assessed RFS Rate at 12 and 24 Months

    Defined as the proportion of patients without documented intrahepatic/extrahepatic HCC recurrence or death from any cause at 12 and 24 months post-treatment, as assessed by the investigator.

    Time frame: At 12 and 24 months post-treatment

  7. OS Rate at 12 and 24 Months

    Defined as the proportion of patients surviving at 12 and 24 months post-treatment initiation.

    Time frame: At 12 and 24 months post-treatment initiation.

  8. Time to Extrahepatic Spread (EHS) or Macrovascular Invasion

    Defined as the time from treatment initiation to the first radiologically or histologically confirmed occurrence of either extrahepatic metastasis or macrovascular invasion (portal/hepatic vein involvement).

    Time frame: From treatment initiation until the date of first documented EHS or macrovascular invasion, assessed up to 24 months.

  9. RFS in PD-L1-High Subgroup or macrovascular invasion (portal/hepatic vein involvement).

    Defined as recurrence-free survival in patients with PD-L1-high expression (predefined as combined positive score \[CPS\] ≥1 by immunohistochemistry) assessed by both investigator and IRF.

    Time frame: From the date of achieving complete response (CR) after surgery until the date of first documented HCC recurrence or death from any cause, whichever comes first, assessed up to 24 months post-surgery.

  10. Incidence of Adverse Events (AEs)

    Defined as the proportion of participants experiencing adverse events, graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Time frame: From the first dose of iparomlimab/tuvonralimab administration until 90 days after the last dose of adjuvant therapy (up to approximately 34 weeks).

07

Study locations

1 of 1 sites recruiting
08

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

Started Aug 2025 (actual). Primary completion is estimated for Dec 2028, 40 months after the start.

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 40 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
Apr 9, 2025
First posted
May 1, 2025
StartActual
Aug 1, 2025
Primary completionEst.
Dec 31, 2028
CompletionEst.
Apr 1, 2029
Last update
Sep 18, 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 Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06954116
Lead sponsor
Tongji Hospital
Responsible party
Ze-yang Ding, MD (Prof., Tongji Hospital) — Principal investigator
First posted
May 1, 2025
Start date
Aug 1, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Sep 18, 2026

Study contacts

Ze-yang Ding, M.D.
Contact
zyding@tjh.tjmu.edu.cn
+8613407156200
Han Gao
Contact
gh1023606887@163.com
+8617730117747
Ze-yang Ding, M.D.
study chair · Tongji Hospital

Oversight

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

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