Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases

Starting soon · Not applicable

Conditions studied: Hepatocellular Carcinoma (HCC), Metastasis

In brief

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.

Key facts

Study ID

NCT07537959

Run by

Tongji Hospital

People needed

280

Starts

2026-04-30

Expected to finish

2031-04-30

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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