This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
560
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS) assessed by blinded independent central review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Time frame: Up to approximately 3 years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 5 years
Progression-free survival (PFS) assessed by investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria.
Time frame: Up to approximately 3 years
Duration of Response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
iv, q2w
iv, q2w