NCT04592029

TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	TACE combined with sintilimab and bevacizumab	Sintilimab and bevacizumab are administered at 3-7 days after the first TACE. The study includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then, Sintilimab 200mg/kg IV. q3w+ select specific dose of bevacizumab (7.5mg/kg or 15 mg/kg IV. q3w), expand to 36-39 patients for the further safety and efficacy study. The study treatment of sintilimab and bevacizumab lasts up to 24 months. TACE can be repeated when indicated clinically.

Timeline

• Start date: 2020-09-27
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2020-10-19
• Last updated: 2021-09-23

Locations

1 site across 1 country: China