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

NCT07490262 | Recruiting Phase 2

• 1 other identifier: CIBI310C302
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 2

Brief Summary

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

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (7)

• Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1.

  up to 2 years

• Phase II: PFS（Progression-Free Survival） assessed by investigator per RECIST 1.1.

  up to 2 years

• Phase II: AEs（Adverse Event）

  up to 2 years

• Phase II: TRAES（Treatment Emergent Adverse Event）

  up to 2 years

• Phase II: SAEs（Serious Adverse Event）

  up to 2 years

• Phase III: OS（Overall Survival）

  up to 2 years

• Phase III: PFS（Progression-Free Survival）assessed by the Independent Radiologic Review Committee (IRRC) per RECIST 1.1.

  up to 2 years

Secondary Outcomes (36)

• Phase II: OS

  up to 2 years

• Phase II: Incidence and characteristics of ADA&Nab.

  up to 2 years

• Phase II: DoR (Duration of Response )

  up to 2 years

• Phase II: DCR (Disease Control Rate )

  up to 2 years

• Phase II: TTR (Time to Response )

  up to 2 years

Study Arms (4)

Control Group

ACTIVE COMPARATOR

Sintilimab+ Bevacizumab

Biological: Bevacizumab; Biological: Sintilimab

Treatment Group2

EXPERIMENTAL

Sintilimab+ IBI310+Bevacizumab

Biological: Bevacizumab; Biological: IBI310; Biological: Sintilimab

Treatment Group3

EXPERIMENTAL

Sintilimab+ IBI310+Oxaliplatin+Capecitabine

Drug: Capecitabine; Drug: Oxaliplatin; Biological: IBI310; Biological: Sintilimab

Treatment Group1

EXPERIMENTAL

Sintilimab+ IBI310+Bevacizumab+Oxaliplatin+Capecitabine

Biological: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin; Biological: IBI310; Biological: Sintilimab

Interventions

Bevacizumab BIOLOGICAL

15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Control Group; Treatment Group1; Treatment Group2

Capecitabine DRUG

1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.

Treatment Group1; Treatment Group3

Oxaliplatin DRUG

85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.

Treatment Group1; Treatment Group3

IBI310 BIOLOGICAL

1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle

Treatment Group1; Treatment Group2; Treatment Group3

Sintilimab BIOLOGICAL

200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Control Group; Treatment Group1; Treatment Group2; Treatment Group3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
• Age ≥18 years and ≤75 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
• No prior systemic antineoplastic therapy for HCC before first dose.
• At screening, per RECIST 1.1, there must be at least one measurable lesion that has not undergone local therapy, or a measurable lesion that has clearly progressed following local therapy (per RECIST 1.1).
• Child-Pugh score ≤7.
• Adequate organ and bone marrow function.
• Expected survival ≥12 weeks at the time of treatment initiation.
• Female participants of childbearing potential, or male participants whose sexual partners are of childbearing potential, must use effective contraception throughout the treatment period and for 15 months after the last dose of oxaliplatin (for females) / 12 months after the last dose of oxaliplatin (for males), or for 6 months after the last dose of any other investigational drug-whichever period ends later.
• Signed written informed consent form, and ability to comply with scheduled visits and all protocol-specified procedures.

You may not qualify if:

• Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.
• History of hepatic encephalopathy or prior liver transplantation.
• Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection:
• Known central nervous system (CNS) metastases or symptomatic spinal cord compression.
• Esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months; Grade 3 (G3) esophageal/gastric varices documented by endoscopy within 3 months prior to first dose; or evidence of portal hypertension.
• Life-threatening hemorrhagic event within the past 3 months, including but not limited to events requiring blood transfusion, surgical or local intervention, or ongoing pharmacologic hemostatic therapy.
• Metastatic lesions invading major vessels, airways, or the mediastinum with clinically significant bleeding risk.
• Arterial or venous thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident (stroke), transient ischemic attack (TIA), pulmonary embolism, deep vein thrombosis, or other severe thromboembolic conditions.
• Portal vein tumor thrombus (PVTT) involving both the main portal vein and left/right branch; PVTT extending into the superior mesenteric vein; or PVTT involving the inferior vena cava.
• Use of aspirin (\>325 mg/day) or other known platelet-function-inhibiting agents (e.g., dipyridamole or clopidogrel) for therapeutic purposes within 10 days prior to randomization. Prophylactic use of anticoagulants is permitted.
• Uncontrolled hypertension: systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.
• Persistent treatment-related toxicities from prior anticancer therapy not resolved to Grade 0 or Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of randomization.
• Symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class II-IV); symptomatic or inadequately controlled arrhythmias; history of congenital long QT syndrome; or baseline corrected QT interval (QTcF, calculated using Fridericia's formula) \>500 ms.
• Severe bleeding diathesis or coagulopathy; or current thrombolytic therapy.

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead

Study Sites (2)

The First Affiliated Hosptial of USTC

Hefei, Anhui, 230001, China

RECRUITING

Zhongshan Hospital, Fudan university

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; Capecitabine; Oxaliplatin; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Haiyun Zuo

CONTACT

021-31852088; Haiyun.zuo@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 24, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (2)