A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients. Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The 307th Hospital of Military Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Heilongjiang Cancer Hospital
Harbin, Heilongjiang, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Progression-free survival (PFS) rate at Week 16
Proportion of patients without PD or death at Week 16
Time frame: Progression-free survival (PFS) rate at Week 16
Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
AE monitored from the first dose to within 30 days after the last dose
Time frame: From first dose to within 30 days after the last dose
Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes
Safety parameters monitored from the first dose to within 30 days after the last dose
Time frame: From first dose to within 30 days after the last dose
Objective response rate (ORR)
Proportion of patients with a best overall CR and PR per RECIST v1.1
Time frame: 6 months after the last patient enrolled
Disease control rate (DCR)
Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
Time frame: 6 months after the last patient enrolled
Duration of response (DoR)
The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death
Time frame: 6 months after the last patient enrolled
Progression-free survival (PFS)
The time from the start date of study drug until the date of objective disease progression or death
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Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, China
Time frame: 6 months after the last patient enrolled
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Time frame: 6 months after the last patient enrolled