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TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:
Transcatheter Arterial Chemoembolization Combined With Sintilimab and Bevacizumab for Unresectable Intermediate and Advanced Hepatocellular Carcinoma: A Prospective Study

Clinical Trial Summary

This study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced hepatocellular carcinoma (HCC).

Clinical Trial Description

This is a Phase Ib study to evaluate the safety and efficacy of TACE combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced HCC. 36-39 subjects with unresectable intermediate or advanced HCC will be enrolled in the study. This study includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety evaluation. Then, sintilimab 200mg/kg IV. every three weeks (q3w) + the select specific dose of bevacizumab 7.5mg/kg (group 1) or 15mg/kg (group2) IV q3w, expand to 36 patients (18 patients each group) for the further safety and efficacy study. Sintilimab and bevacizumab will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. And the study treatment of sintilimab and bevacizumab will last 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04592029
Study type Interventional
Source Second Affiliated Hospital of Guangzhou Medical University
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 27, 2020
Completion date December 31, 2022
View Details
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