NCT05924997

Adebrelimab, Camrelizumab Plus Apatinib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Trial Evaluating the Efficacy and Safety of Adebrelimab, Camrelizumab Plus Apatinib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, phase Ib/II trial . The objective of this study is to evaluate the efficacy and safety of adebrelimab, camrelizumab plus apatinib as first-line therapy in patients with advanced hepatocellular carcinoma

Detailed description

This study is divided into two stages: in the Ib stage, the tolerance and safety of adebrelimab, camrelizumab plus apatinib in the treatment of patients with advanced solid tumors were studied; The second phase is a single-arm, open and multi-center clinical study. The improvement of objective response rate (ORR) in patients with advanced HCC by first-line treatment with adebrelimab, camrelizumab plus apatinib was observed and evaluated. ■ The first stage In order to effectively investigate the safety of adebrelimab, camrelizumab plus apatinib in the treatment of patients with advanced solid tumors, the following cohort (dose level) studies are planned: Queue 1: adebrelimab 10mg/kgQ3W+ camrelizumab 200mgQ3W+ apatinib 250mgqd. Queue 2: adebrelimab 20mg/kgQ3W+ camrelizumab 200mgQ3W+ apatinib 250mgqd. Using i3+3 design, 3\~6 subjects are expected to be enrolled in each cohort. Every 3 weeks (21 days) is a treatment cycle, and DLT observation period is the first and second cycles of combined administration. After passing the safety evaluation of DLT observation period, the next dose group experiment can be gradually entered. ■ The second stage According to the results of the first phase, the recommended dose of phase II study (RP2D) was selected for further efficacy and safety evaluation in patients with advanced hepatocellular carcinoma who had not received systematic treatment before. The objective remission rate (ORR) was the main end point of the study, and 46 subjects were planned to be enrolled. After fully knowing and signing the informed consent form, the subjects will receive the study treatment: adebrelimab (RP2D, Q3W)+ camrelizumab 200mgQ3W+ apatinib 250mgqd, with 3 weeks (21 days) as a treatment cycle.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	adebrelimab, camrelizumab plus apatinib	adebrelimab (RP2D, Q3W)+ camrelizumab 200mg Q3W+ apatinib 250mg qd, with 3 weeks (21 days) as a treatment cycle

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-06-29
• Last updated: 2024-02-21

Locations

1 site across 1 country: China