This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China
RECRUITINGObjective Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Progress Free Survival
Time from treatment beginning until disease progression
Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Overall Survival
Time from treatment beginning until death from any cause
Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Incidence of Treatment-related adverse Events
Time frame: Through study completion, an average of 1 months
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