The purpose of this study is to evaluate the efficacy and safety of QL1706 Injection in combination with bevacizumab and XELOX compared with placebo in combination with bevacizumab and XELOX for first-line treatment in patients with unresectable mCRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
430
QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of QL1706 lasts for up to 2 years.
Bevacizumab will be administered by IV infusion at 7.5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Bevacizumab lasts for up to 2 years.
Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC)
PFS is defined as the time from randomization to the first documented progressive disease or deaths (whichever comes first), assessed per RECIST v1.1 criteria.
Time frame: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from the randomization to deaths, regardless of the cause of deaths
Time frame: Approximately 66 months
Progression Free Survival (PFS) Assessed by Investigator
OS is defined as the time from the randomization to deaths, regardless of the cause of deaths
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Time frame: Approximately 36 months
Duration Of Response (DOR)
ORR is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Time frame: Approximately 36 months
Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs).
Adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events are included. The investigator should carry out judgment for investigational drug correlation
Time frame: From the subject signs the ICF to 30 days after the last dose of study drug is administered
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Oxaliplatin will be administered by IV infusion at 130 mg/m2 on Day 1 of each 21-day cycle up to 8 treatment cycles.
Capecitabine will be administered orally at 1000 mg/m2 twice daily for 2 consecutive weeks, followed by one-week rest in each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Capecitabine lasts for up to 2 years.
Placebo will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Placebo lasts for up to 2 years.