Immunotherapy Clinical Trial
Official title:
Combination of Sintilimab and Stereotactic Body Radiotherapy in Advanced Metastatic Hepatocellular Carcinoma
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.
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.
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