This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate (ORR)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle