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NCT07537946

PHASE3

Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.

Official title: Comprehensive Local Consolidative Therapy Versus Continued Sintilimab Plus Lenvatinib Alone After Induction Sintilimab Plus Lenvatinib in Patients With Oligo-Extrahepatic Metastatic Hepatocellular Carcinoma: A Multicenter Prospective Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-05-30

Completion Date

2031-07-30

Last Updated

2026-04-17

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)Metastases

Interventions

DRUG

Sintilimab

Sintilimab 200 mg administered as an intravenous infusion every 3 weeks during induction and continued after randomization until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or a maximum duration of 24 months, according to protocol.

DRUG

Lenvatinib

Lenvatinib administered orally once daily during induction and continued after randomization until disease progression or unacceptable toxicity. The recommended dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Dose interruption, reduction, and discontinuation are managed according to protocol and product labeling.

PROCEDURE

Comprehensive Local Consolidative Therapy

Protocol-specified comprehensive local consolidative therapy directed at all residual active lesions after induction treatment, including stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof, performed within 4 to 8 weeks after randomization.

Inclusion Criteria: * Age 18 to 75 years * Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards * Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs * At least 1 measurable lesion according to RECIST version 1.1 * No prior systemic therapy for advanced or metastatic hepatocellular carcinoma * ECOG performance status 0 to 1 * Child-Pugh class A or stable Child-Pugh B7 * Adequate hematologic, hepatic, renal, and coagulation function according to protocol * Baseline center multidisciplinary team assessment indicating potential feasibility for complete consolidative intent if disease control is achieved after induction * Written informed consent and willingness to comply with treatment, follow-up, and protocol-required assessments Exclusion Criteria: * More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs * Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases * Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction * Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment * Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC * Active autoimmune disease requiring systemic immunosuppression * Active severe infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or uncontrolled hepatitis B without appropriate antiviral therapy * Gastrointestinal bleeding within the previous 6 months, or untreated or uncontrolled high-risk gastroesophageal varices * Uncontrolled hypertension, recent major thrombotic event, myocardial infarction, unstable angina, or stroke * Active interstitial lung disease or noninfectious pneumonitis requiring systemic treatment * Severe proteinuria or renal dysfunction considered unsuitable for lenvatinib treatment * Pregnancy or breastfeeding * Any condition that, in the investigator's judgment, would make participation unsafe or compromise protocol compliance

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China