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

adebrelimab, camrelizumab plus apatinib

Lei Zhang, PhD

Yin Long

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

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.

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

The proportion of subjects who achieved complete response (CR; all target lesions disappeared) or partial response (PR; the sum of the longest diameter of target lesions decreased by ≥ 30%) according to the RECIST1.1 standard.

The proportion of subjects who achieved complete response (CR; the disappearance of any intratumoural arterial enhancement in all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest viable tumour diameters of target lesions) according to the mRECIST standard.

The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of adebrelimab, camrelizumab plus apatinib as first-line therapy in patients with advanced hepatocellular carcinoma.

The period of time from the start of treatment to progressive disease\[PD\] or death.

The period of time from the days which achieved complete response \[CR\] or partial response\[PR\] to progressive disease\[PD\].

The proportion of the sum of complete response \[CR\]、partial response \[PR\]、stable disease\[SD\] among the total cases.

The period of time from the start of treatment to progressive disease \[PD\].

The period of time from the start of treatment to death from any cause.

Spots Global Cancer Trial Database for adebrelimab, camrelizumab plus apatinib