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

Starting soon · Not applicable

Conditions studied: HCC - Hepatocellular Carcinoma, TP53 Gene Mutation, Unresectable, Resistant Cancer

In brief

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.

Key facts

Study ID

NCT07535840

Run by

Tongji Hospital

People needed

25

Starts

2026-05-01

Expected to finish

2027-06-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and sign written informed consent prior to any study-related procedures.
• Age ≥18 years at the time of signing informed consent.
• Histologically or cytologically confirmed advanced or unresectable hepatocellular carcinoma (HCC).
• Documented disease progression after prior systemic immunotherapy, including at least one PD-(L)1 inhibitor.
• Confirmed TP53 mutation in fresh liver tumor tissue by central laboratory testing.
• Determined by liver tumor MDT to be unsuitable for curative surgery (R0 resection not feasible, insufficient normal liver volume, or other criteria).
• BCLC stage B or C.
• At least one measurable lesion per RECIST v1.1 confirmed by BICR.
• ECOG performance status 0-1.
• Child-Pugh class A within 7 days prior to randomization.
• Adequate organ and bone marrow function within 7 days prior to enrollment:
• ANC ≥1.5×10\^9/L, Platelets ≥75×10\^9/L, HGB ≥9 g/dL
• TBIL ≤2×ULN, ALT/AST ≤5×ULN, Albumin ≥28 g/L, ALP ≤5×ULN
• Creatinine ≤1.5×ULN or CCr ≥50 mL/min, urine protein <2+ (or 24-h urine protein <1 g if baseline ≥2+)
• INR ≤2.3 or PT prolongation ≤6 sec
• Expected survival ≥12 weeks.
• Women of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 6 months after last dose.
• Ability and willingness to comply with study procedures and visits.

You may not qualify if…

• Candidates suitable for local curative therapy.
• Mixed liver tumors containing sarcomatoid or intrahepatic cholangiocarcinoma components.
• Hematologic malignancies.
• History of hepatic encephalopathy or prior liver transplantation.
• Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; asymptomatic small effusions allowed.
• Active HBV (HBV DNA >2000 IU/mL) or HCV (HCV RNA >10\^3 copies/mL) infection; co-infection HBsAg+/HCV Ab+ excluded.
• CNS metastases.
• Significant recent variceal bleeding (within 6 months).
• Life-threatening hemorrhagic events within 3 months.
• Significant thromboembolic events within 6 months.
• Use of high-dose aspirin (>325 mg/day) or other platelet inhibitors within 2 weeks prior to first dose.
• Unresolved grade ≥2 toxicities from prior therapies (excluding hair loss or asymptomatic lab abnormalities).
• Symptomatic heart failure NYHA II-IV or LVEF <50%.
• Uncontrolled arrhythmias or congenital long QT syndrome, QTc >500 ms.
• Active bleeding disorders or on thrombolytic therapy.
• Recent history of gastrointestinal perforation, fistula, obstruction, or significant bowel disease.
• Radiotherapy within 3-7 weeks prior to first dose with residual toxicity.
• History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced lung injury, or severe impaired lung function.
• Active tuberculosis or treatment for TB within 1 year.
• HIV infection or active, untreated syphilis.
• Active or uncontrolled severe infection within 4 weeks prior to first dose.
• Active autoimmune disease requiring systemic treatment within 2 years. Known primary immunodeficiency.
• Use of systemic immunosuppressants within 4 weeks prior to first dose (nasal/inhaled steroids at physiologic dose allowed).
• Receipt of live attenuated vaccines within 4 weeks prior to first dose.
• Major surgery within 4 weeks prior to first dose, or unhealed wounds. Minor procedures like IV lines excluded.

Full record on ClinicalTrials.gov

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