Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Primary Tumor Resection
- Protocol-Allowed First-Line Immune-Based Systemic Therapy
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov