The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer
Study Type
OBSERVATIONAL
Enrollment
10
Patients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W
Yang Jianjun
Xi’an, Shanxi, China
RECRUITINGAE
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
Time frame: 2-year
ORR
Objective response rate (ORR): Defined as the proportion of patients who achieved a prespecified reduction in tumor volume and maintained a minimum duration, including cases with CR and PR. Objective tumor response was assessed by an independent review committee using the Response Assessment Criteria for solid Tumors (RECIST 1.1 criteria).
Time frame: 1-year
DCR
The proportion of all subjects who were randomized and whose best overall response (BOR) was complete response (CR), partial response (PR), and stable disease (SD) according to RECIST1.1 criteria.
Time frame: 1-year
OS
It was defined as the time between the start of randomization and the death of the subject from any cause and was calculated in the intention-to-treat population (ITT).
Time frame: 2-year
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