NCT04547452

Combination of Sintilimab and Stereotactic Body Radiotherapy in Advanced Metastatic HCC

Combination of Sintilimab and Stereotactic Body Radiotherapy in Advanced Metastatic Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular carcinoma (HCC) is a common malignancy, and more than 70% of newly diagnosed HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as first-line options for advanced HCC. The PD-1 monoclonal antibody，such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA. Combining radiotherapy with immune checkpoints showed promising response rates and improved survival in several solid tumor types. The purpose of this randomized study is to determine whether stereotactic body radiation therapy (SBRT) combined with sintilimab (an anti-PD-1 antibody) will improve the response to the anticancer treatment compared to sintilimab alone in patients with advanced HCC. About 84 participants will be enrolled in this study. All will take part at West China Hospital, Sichuan University.

Detailed description

A total of 84 HCC patients who are failure from the first line Sorafenib or lenvatinib treatment will be randomized to two treatment arms using a 1:1 ratio: SBRT + PD-1 arm or PD-1 alone arm. Patients in both arms will receive sintilimab administered intravenously at 200 mg every 3 weeks. Stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3-6 fractions over 1-2 weeks. In the SBRT + PD-1 arm, sintilimab is administered intravenously at 200 mg every 3 weeks for up to 1 year. The first course of sintilimab will be given within 4-6 weeks after completion of SBRT.

Conditions

• Stage IV HCC
• Immunotherapy
• SBRT

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiation therapy	Sintilimab Combined with SBRT
DRUG	Anti-PD-1 antibody drug named Sintilimab	Sintilimab

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-01
• Completion: 2023-07-01
• First posted: 2020-09-14
• Last updated: 2020-09-14

Locations

1 site across 1 country: China