NCT07192848

Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy

Efficacy and Safety of Adebrelimab Plus Apatinib in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Systemic Therapy: A Single-arm, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Song Peng · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, patients with locally advanced unresectable or metastatic hepatocellular carcinoma who have previously received systemic therapy (targeted therapy with or without immunotherapy) and developed drug resistance and progression will be selected as the research subjects. The study takes the objective response rate (ORR) as the primary endpoint. It is planned to enroll 47 subjects. Eligible patients will receive adebrelimab in combination with apatinib for treatment. After subjects are fully informed, sign the informed consent form, and pass the screening, they will receive the study treatment. Adebrelimab will be administered at a fixed dose of 1200 mg by intravenous infusion on D1, once every 21 days (Q3W). It will be combined with apatinib at a dose of 250 mg (0.25 g), taken orally once a day (QD), and continuously administered. A 3 - week (21 - day) period will be considered one treatment cycle. The study treatment will continue until the subject experiences intolerable toxic reactions, withdraws informed consent, disease progression confirmed by the investigator according to RECIST v1.1 (when a subject has disease progression as defined by RECIST v1.1, if the investigator assesses that the subject still has clinical benefits and can tolerate the study treatment, the subject may continue to receive the study drug; if it is considered that the subject no longer has clinical benefits, the treatment may be terminated), or other treatment termination criteria specified in the protocol, whichever occurs first. After subjects are enrolled in the study, safety follow - up visits will be conducted on D1 of each treatment cycle. Imaging examinations will be performed once every 2 treatment cycles (6 - 8 weeks) to evaluate the efficacy. After the end of treatment, safety follow - up visits and survival follow - up will continue.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	Adebrelimab + Apatinib	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: China