To explore the safety and efficacy of Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of Surufatinib combined with a fixed dose of Sintilimab and Capecitabine using 3 + 3 dose climbing experiment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Surufatinib will be given 200/250 mg po. qd.
Sintilimab administered IV at a dose of 200mg every 3 weeks.
Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.
Time frame: 2 year
Objective response rate (ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time frame: 2 year
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: 2 year
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Time frame: 2 year
Safety variables (Incidence of Adverse Events [Safety and Tolerability])
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: 2 year
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