A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of QL1203 and Placebo Respectively Combined With Chemotherapy in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 2
- 主要终点
- Progression-free Survival（PFS）
研究概览
简要总结
The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.
详细描述
The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
mFOLFOX6 + 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
干预措施: QL1203 (Drug)
mFOLFOX6 + 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
干预措施: mFOLFOX6 regimen (Drug)
mFOLFOX6 + 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.
干预措施: Placebo (Drug)
mFOLFOX6 + 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.
干预措施: mFOLFOX6 regimen (Drug)
结局指标
主要结局
Progression-free Survival（PFS）
时间窗: 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.
次要结局
未报告次要终点