NCT04072679

Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma

Evaluation of the Safety and Efficacy of Sintilimab Combined With IBI305 in the Treatment of Advanced Hepatocellular Carcinoma in a Single-center, One-arm, and Phase Ib Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.

Detailed description

This study is to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China. Approximately 26-38 subjects with locally advanced or metastatic hepatocellular carcinoma will be enrolled in the study. It includes dose escalation and dose expansion stage. 12-18 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 20 patients for the further safety and efficacy study. The study treatment lasts up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab+IBI305	It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.

Timeline

• Start date: 2018-10-11
• Primary completion: 2020-03-31
• Completion: 2020-11-11
• First posted: 2019-08-28
• Last updated: 2021-02-01

Locations

1 site across 1 country: China