NCT04104074

Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis

A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

Detailed description

The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.

Conditions

• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombosis

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
DRUG	Sintilimab	Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks

Timeline

• Start date: 2019-11-25
• Primary completion: 2021-07-31
• Completion: 2021-12-31
• First posted: 2019-09-26
• Last updated: 2020-07-07

Locations

1 site across 1 country: China