NCT07537946Not yet recruitingPhase 3
Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
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
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- May 2026
- Primary completion date
- May 2031
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07537946
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From May 2026 to the primary completion date, May 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC
- Gastrointestinal bleeding within the previous 6 months, or untreated or uncontrolled high-risk gastroesophageal varices
Other illness
- 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
- 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
- Uncontrolled hypertension, recent major thrombotic event, myocardial infarction, unstable angina, or stroke
- Active interstitial lung disease or noninfectious pneumonitis requiring systemic treatment
- Any condition that, in the investigator's judgment, would make participation unsafe or compromise protocol compliance
Other
- More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs
- Severe proteinuria or renal dysfunction considered unsuitable for lenvatinib treatment
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.