This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC).
This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC). About 200 subjects are prepared to recruit in the study.
Study Type
OBSERVATIONAL
Enrollment
200
The study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected.
Progression-free survival (PFS)
PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.
Time frame: 6 months after the last patient enrolled
Safty
The rate of AE and SAE in patients with BTC receiving surufatinib,AEs/SAEs were evaluated using NCI-CTCAE v5.0
Time frame: up to 4 weeks after the last dose
Disease Control Rate(DCR)
DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).
Time frame: 6 months after the last patient enrolled
Overall survival (OS)
OS was defined as the length of time from the administration of the first-dose until death from any cause. or lost of follow-up
Time frame: 6 months after the last patient enrolled
Objective Response Rate (ORR)
ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).
Time frame: 6 months after the last patient enrolled
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