QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

Recruitment & Eligibility

Inclusion Criteria

Diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on.
Man or woman at least 18 years old.
At least one measurable lesion can be evaluated according to Response Evaluation Criteria In Solid Tumors 1.1（RECIST1.1） criteria.
Eastern Cooperative Oncology Group (ECOG) performance status should be 0-1 before randomization.
The level of organ function must meet the requirements before randomization.
Prior to randomization, the damage caused by other treatments had recovered to < grade 2 (CTCAE version 4.03).

Exclusion Criteria

Prior systemic or local chemotherapy for colorectal cancer，except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence> 6 months。
Prior epithelial growth factor receptor(EGFR)-targeted drugs for colorectal cancer.
Presence of central nervous system (CNS) metastases before the informed consent was signed, except for those who had stabilized CNS metastases for more than 4 weeks and had no symptoms after treatment.
History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment.
History of interstitial lung disease.
Existing intestinal obstruction before randomization, active inflammatory bowel disease.
Patients with non-healing abdominal fistula and gastrointestinal perforation before randomization.
There were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.

Study & Design

Arm && Interventions

Group	Intervention	Description
mFOLFOX6 + Placebo	mFOLFOX6 regimen	Participants received Placebo，6 mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
mFOLFOX6 + QL1203	mFOLFOX6 regimen	Participants receive QL1203, 6mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity
mFOLFOX6 + QL1203	QL1203	Participants receive QL1203, 6mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity
mFOLFOX6 + Placebo	Placebo	Participants received Placebo，6 mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival（PFS）	From randomization until disease progression up to 12 months	Progression-free survival (PFS), assessed by blinded independent central review committee, is defined as the time from randomization to disease progression per RECIST v1.1 criteria or death.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility