Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy

Sponsor
Song Peng
Study ID
NCT07192848
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab + Apatinib — DRUG
    Adebrelimab: A fixed dose of 1200 mg is administered as an intravenous infusion over 30 minutes (not less than 20 minutes and not more than 60 minutes, including the flushing phase), once every 3 weeks (Q3W). The interval between two administrations should not be less than 12 days. The maximum treatment duration is 6 courses. Apatinib: 250 mg, once daily (QD), taken orally within half an hour after a meal, continuously, with a 3 - week (21 - day) cycle. The maximum treatment duration is 6 courses.

Study Details

Patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who progressed after prior systemic therapy (targeted ± immunotherapy) are enrolled. Primary endpoint: objective response rate (ORR). Planned enrollment: 47 subjects. Eligible patients receive adebrelimab + apatinib. After informed consent and screening, treatment starts: Adebrelimab 1200mg IV on D1, Q3W; apatinib 250mg oral QD, continuous. 21-day cycle. Treatment continues until intolerable toxicity, consent withdrawal, RECIST v1.1-proven progression (may continue if clinically beneficial), or protocol-specified criteria (whichever first). Safety follow-up on D1 of each cycle; imaging every 2 cycles (6-8 weeks) for efficacy. Post-treatment: continued safety and survival follow-up.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab + Apatinib Treatment Arm
    This arm involves patients receiving adebrelimab (1200mg, intravenous infusion on D1, Q3W) combined with apatinib (250mg, oral, QD). Treatment continues until intolerable toxicity, withdrawal of consent, disease progression, or other protocol - defined criteria.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to one year ]

Central Contacts

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