This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.
Eligible patients will receive:
Fuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.
Safety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.
Primary Objective: To assess the objective response rate (ORR) of the combination therapy.
Secondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.
Ability to understand and sign written informed consent prior to any study-related procedures.
Candidates suitable for local curative therapy.
Single group
Firsekibart + Tislelizumab + Lenvatinib
DrugParticipants will receive Firsekibart 200 mg IV on Day 1 every 3 weeks, followed 1 hour later by Tislelizumab 200 mg IV on Day 1 every 3 weeks, and Lenvatinib orally once daily (8 mg for ≤60 kg or 12 mg for \>60 kg). Treatment continues until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or other protocol-specified discontinuation criteria.
Objective Response Rate (ORR) per RECIST v1.1
The proportion of patients achieving complete response (CR) or partial response (PR) as assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria. Responses must be confirmed at least 4 weeks after initial documentation.
Objective Response Rate (ORR) in patients with unresectable TP53-mutant advanced HCC
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria, confirmed by imaging at least 4 weeks after the initial response. Assessments include CT or MRI scans performed every 6 weeks (±7 days) during treatment.
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This trial is not recruiting at the moment. You can still explore other options:
