A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.
China, Fujian
Fuzhou, Fujian, China
RECRUITINGObjective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Progression Free Survival (PFS)
To assess the efficacy of Surufatinib Combined With Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: up to 12 months
Overall survival time
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
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