Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Tumor Resection | Procedure | — | UNRESOLVED |
| Protocol-Allowed First-Line Immune-Based Systemic Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Systemic Therapy Alone
- description
- Participants receive protocol-allowed first-line immune-based systemic therapy without planned primary tumor resection. Optional HAIC may be used according to clinical need and will be recorded. Unplanned surgery after randomization will be recorded but will not change the original group assignment for the primary analysis.
- interventionNames
- Other: Protocol-Allowed First-Line Immune-Based Systemic Therapy
- type
- EXPERIMENTAL
- label
- Primary Tumor Resection Plus Systemic Therapy
- description
- Participants undergo resection of the primary intrahepatic tumor with curative intent (R0 intent) followed by protocol-allowed first-line immune-based systemic therapy after adequate postoperative recovery. Optional HAIC may be used according to clinical need and will be recorded.
- interventionNames
- Procedure: Primary Tumor Resection
- Other: Protocol-Allowed First-Line Immune-Based Systemic Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available