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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Sintilimab Combined with SBRT
Sintilimab
West China Hospital
Chengdu, Sichuan, China
RECRUITING24-week progression-free survival (PFS) ratev
The proportion of patients with progression disease according to mRECIST at 24 weeks from randomization.
Time frame: 24 weeks after radiotherapy
Objective Response Rate (ORR)
Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing LDRT and the tumor which do not receive radiotherapy.
Time frame: up to 24 months after the enrollment
Overall Survival (OS)
OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause
Time frame: up to 24 months after the enrollment
24-week disease control rate (DCR)
The proportion of patients with complete response, partial response or stable disease according to mRECIST at 24 weeks from randomization.
Time frame: 24 weeks after radiotherapy
Duration of response (DOR)
From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 24 months.
Time frame: up to 24 months after the enrollment
Adverse Events
Treatment-related adverse events are graded according to the Common Toxicity Criteria, version 4.0, and were registered from the date of informed consent until discontinuation of trial treatment.
Time frame: 2 years from randomization
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