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A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma

NCT07535840 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

  • HCC - Hepatocellular Carcinoma
  • TP53 Gene Mutation
  • Unresectable
  • Resistant Cancer

Interventions

DRUG

Firsekibart + Tislelizumab + Lenvatinib

Participants 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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535840 on ClinicalTrials.gov