Primary Tumor Resection: Surgical resection of the primary liver tumor with curative intent (R0 intent), using anatomic or non-anatomic hepatectomy as appropriate based on tumor location, liver reserve, and operative risk.
Protocol-Allowed First-Line Immune-Based Systemic Therapy: Guideline-concordant first-line immune-based systemic therapy. Preferred regimens include PD-1/PD-L1 inhibitor plus anti-angiogenic therapy. PD-1 inhibitor plus multikinase targeted therapy is allowed when anti-angiogenic therapy is contraindicated or not feasible. Concurrent use of more than one PD-1/PD-L1 agent is not permitted.
Study summary
This study will evaluate whether resection of the primary liver tumor, in addition to standard first-line systemic therapy, improves survival in patients with hepatocellular carcinoma that has spread outside the liver but still has a resectable primary intrahepatic tumor. Participants will be randomly assigned to receive either primary tumor resection followed by protocol-allowed first-line immune-based systemic therapy or systemic therapy alone. The primary outcome is overall survival. Secondary outcomes include progression-free survival, objective response rate, disease control rate, immune-related adverse events, postoperative complications, and quality of life.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18 to 75 years
* Hepatocellular carcinoma confirmed by imaging and/or histology according to AASLD or EASL criteria
* Resectable primary intrahepatic tumor with expected R0 resection
* ECOG performance status 0 to 1
* At least one measurable extrahepatic metastatic lesion according to RECIST version 1.1
* Child-Pugh class A or stable Child-Pugh B7
* Written informed consent and willingness to comply with study follow-up and data collection
Exclusion Criteria:
* Prior systemic therapy for hepatocellular carcinoma, including immunotherapy, targeted therapy, or chemotherapy
* Decompensated or clinically unstable liver disease, including refractory ascites, recurrent hepatic encephalopathy, active gastrointestinal bleeding, or - Child-Pugh class greater than B7
* Major bleeding risk or clinically significant coagulation abnormality, including recent gastrointestinal bleeding or untreated/high-risk gastroesophageal varices
* Active autoimmune disease or long-term systemic immunosuppressive therapy
* Active severe infection, including uncontrolled bacterial or fungal infection, uncontrolled hepatitis B virus replication without appropriate antiviral treatment, or active tuberculosis
* Uncontrolled central nervous system metastases
* Uncontrolled cardiovascular disease, including poorly controlled hypertension, recent myocardial infarction, unstable angina, stroke, or major thrombotic event
* Significant proteinuria or renal dysfunction considered unsuitable for study treatment
* Another active malignancy, except for selected low-risk malignancies allowed by the investigator and ethics committee
* Pregnancy or breastfeeding
* Known severe hypersensitivity to study-related drugs
* Poor compliance, psychiatric or cognitive disorder preventing study participation, or any other condition judged by the investigator to make the participant unsuitable for the trial
Primary outcome measure(s)
Overall Survival — From randomization until death from any cause, assessed up to 60 months Overall survival is defined as the time from randomization to death from any cause.
Trial sites (1)
Facility
City
Region
Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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