A Phase 2 interventional study of Stereotactic body radiotherapy and Sintilimab in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC.
A total of 140 patients with recurrent or residual small HCC will be stratified according to tumor diameter (≤3 vs. >3 cm) and tumor type (recurrent vs. residual) and randomly assigned (1:1) to receive stereotactic body radiotherapy (SBRT) with or without adjuvant sintilimab for 6 cycles (200 mg, once every 3 weeks, with the first dose within 1 week after the completion of SBRT).
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 140 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in both cohorts will receive SBRT using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3 fractions over 1 week. Then patients in the study group (arm A) will receive sintilimab as adjuvant therapy for up to 6 cycles after the completion of radiotherapy.
Radiation: Stereotactic body radiotherapy · Drug: Sintilimab
Patients in both cohorts will receive SBRT using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3 fractions over 1 week. Then patients in the control group (arm B) will be followed up regularly.
Radiation: Stereotactic body radiotherapy
Patients in both cohorts will receive SBRT using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3 fractions over 1 week.
Also known as: SBRT
Patients received sintilimab 200 mg every 3 weeks for up to 6 cycles, with the first dose within 1 week after the completion of SBRT.
Also known as: IBI308
Progression-free survival (PFS) rate
Two-year follow-up from the date of enrollment to the date of disease progression or last follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months
Overall survival
Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months
Local control rate (DCR)
The proportion of patients with complete response, partial response, or stable disease for the target lesion according to RECIST criteria.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
Correlation between serum cytokines and overall survival and immune-related adverse events
The correlation between dynamic change of serum cytokines (IL-2R, IL-6, IL-13, IL-8, CCL3, CD40, and CD274) during treatment and survival outcomes and immune-related adverse events.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months
Correlation between ctDNA and overall survival
The correlation between dynamic change of ctDNA (before and after treatment) and survival outcomes.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months
Plan to share: No — No plan to make individual participant data (IPD) available to other researchers.
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