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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Primary Tumor Resection
Procedure/SurgerySurgical 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
Other interventionGuideline-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.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Systemic Therapy AloneActive comparator 1 intervention
Group B: Primary Tumor Resection Plus Systemic TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame
From randomization until death from any cause, assessed up to 60 monthsSecondary outcomes
1
Progression-Free Survival
Progression-free survival is defined as the time from randomization to disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame
From randomization until radiographic disease progression or death, assessed up to 60 months2
Objective Response Rate
Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1. In the experimental arm, lesions planned for resection are not selected as baseline target lesions.
Time frame
Assessed from randomization through disease progression, up to 60 months3
Disease Control Rate
Disease control rate is defined as the proportion of participants with complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame
Assessed from randomization through disease progression, up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov
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