The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
ORR (objective response rate)
the proportion of patients who have a partial or complete response to therapy.
Time frame: through study completion, up to 2 year
PFS (progression-free survival)
defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Time frame: through study completion, up to 2 year
OS (overall survival)
defined as the time from receiving treatment until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Time frame: through study completion, up to 2 year
DCR (disease control rate)
the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Time frame: through study completion, up to 2 year
LCR (local control rate)
the percentage of lesions with absence of recurrence within the high-dose region (80% isodose volume)
Time frame: through study completion, up to 2 year
Adverse effects
Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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Time frame: through study completion, up to 2 year