NCT07537959Not yet recruiting
Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases
Primary Tumor Resection Plus Systemic Therapy Versus Systemic Therapy Alone in Hepatocellular Carcinoma With Extrahepatic Metastases: A Multicenter Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- 30 Apr 2026
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07537959
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 30 Apr 2026 to the primary completion date, 30 Apr 2026
- 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 systemic therapy for hepatocellular carcinoma, including immunotherapy, targeted therapy, or chemotherapy
Other illness
- 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 cardiovascular disease, including poorly controlled hypertension, recent myocardial infarction, unstable angina, stroke, or major thrombotic event
- Another active malignancy, except for selected low-risk malignancies allowed by the investigator and ethics committee
- 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
Other
- Uncontrolled central nervous system metastases
- Significant proteinuria or renal dysfunction considered unsuitable for study 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 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
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.