Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT07490262

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2026-04-16

680

Participants Needed

2

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
  • Age 18 years and older, up to 75 years.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
  • Barcelona Clinic Liver Cancer (BCLC) Stage C, or Stage B unsuitable for curative surgery or locoregional therapy.
  • No prior systemic antineoplastic therapy for HCC before first dose.
  • At least one measurable lesion not treated with local therapy or clearly progressed after local therapy per RECIST 1.1.
  • Child-Pugh score 7 or less.
  • Adequate organ and bone marrow function.
  • Expected survival of at least 12 weeks at treatment start.
  • Females of childbearing potential and males with partners of childbearing potential must use effective contraception during treatment and specified periods after last dose.
  • Signed informed consent and ability to comply with study procedures.
Not Eligible

You will not qualify if you...

  • Diagnosis of fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatic malignancies.
  • History of hepatic encephalopathy or liver transplantation.
  • Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; minimal asymptomatic effusions allowed.
  • Active hepatitis B or C infection.
  • Known central nervous system metastases or symptomatic spinal cord compression.
  • Recent esophageal or gastric variceal bleeding or portal hypertension.
  • Life-threatening bleeding events within past 3 months.
  • Metastatic lesions invading major vessels, airways, or mediastinum with bleeding risk.
  • Arterial or venous thromboembolic event within past 6 months.
  • Portal vein tumor thrombus involving main portal vein and branches or extending into major veins.
  • Use of high-dose aspirin or platelet-function inhibitors within 10 days prior to randomization.
  • Uncontrolled hypertension or history of hypertensive crisis.
  • Unresolved toxicities from prior anticancer therapy.
  • Symptomatic heart failure, arrhythmias, long QT syndrome, or QT interval over 500 ms.
  • Severe bleeding disorders or current thrombolytic therapy.
  • Recent gastrointestinal perforation, fistula, obstruction, inflammatory bowel disease, or chronic diarrhea.
  • Prior radiotherapy within 3 weeks before randomization.
  • Significant pulmonary disease.
  • Active or recent tuberculosis.
  • HIV infection.
  • Active or uncontrolled severe infection.
  • Active autoimmune disease or history within past 2 years.
  • Recent systemic immunosuppressive therapy.
  • Recent live attenuated vaccine.
  • Major surgery or unhealed wounds within 4 weeks prior.
  • Recent local therapy for HCC within 4 weeks prior.
  • Use of Traditional Chinese Medicine with antitumor effects or immunomodulators within 2 weeks prior.
  • Uncontrolled metabolic disorders, organ dysfunction, systemic illness, or paraneoplastic syndromes posing risk.
  • Another primary cancer diagnosed within 5 years.
  • Prior immune checkpoint inhibitor therapy.
  • Hypersensitivity to study drugs or severe allergic reactions to monoclonal antibodies.
  • Participation in another interventional trial within 4 weeks.
  • Pregnancy or breastfeeding.
  • Any other condition increasing risk or interfering with study participation as judged by investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hosptial of USTC

Hefei, Anhui, China, 230001

Actively Recruiting

2

Zhongshan Hospital, Fudan university

Shanghai, Shanghai Municipality, China, 200032

Not Yet Recruiting

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Research Team

H

Haiyun Zuo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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