A Randomized, Double-blind, Parallel Controlled Phase III Study of Gentuximab Injection Combined With Paclitaxel Injection Versus Placebo Combined With Paclitaxel Injection for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection.
详细描述
It was planned to enroll 752 subjects, grouped according to a 1:1 ratio, with 376 cases each in the experimental group and the control group.
Screening period:
Screening period assessments were performed within 28 days prior to randomization. Patients are screened after signing the informed consent form (ICF), complete relevant laboratory tests and imaging evaluations (including physical examination, vital signs, height, weight, ECOG score, laboratory tests, 12-lead ECG, echocardiography, chest, abdomen, pelvic contrast/contrast CT and head enhancement MRI, whole body bone scan, etc.), and subjects who meet the inclusion criteria and do not meet the exclusion criteria can be enrolled.
Treatment period:
All eligible participants were randomly assigned to the following two groups in a 1:1 ratio based on stratified factors (time to randomization < 6 months or ≥ months from the start of first-line therapy):
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~75 years old (including boundary value), male and female.
- •Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma diagnosed by histology have developed disease after receiving first-line treatment containing platinum and fluorouracil for at least one cycle.
- •It is necessary to make sure that the Her-2 expression status is negative or Her-2 positive and fails to be treated with anti-Her-2 targeted drugs.
- •There is at least one measurable focus according to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors.
- •The physical condition score of the Eastern Cancer Cooperation Group (ECOG) was 0 or
- •The expected life is at least 3 months.
- •Weight ≥ 40 kg, or BMI ≥ 17.
排除标准
- •• Have received any systemic treatment targeting VEGF or VEGFR signal pathway.
- •Have received systemic treatment of paclitaxel, docetaxel and paclitaxel for injection (albumin binding type).
- •Those who are allergic to antibody-like recombinant protein drugs, paclitaxel and its excipients.
- •Have received chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy and other systemic anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the drug.
- •Have undergone major surgery within 4 weeks before the first administration.
- •Thromboembolism occurred within 6 months before screening.
- •Be receiving anticoagulant treatment with warfarin or similar preparations.
- •Severe hemorrhagic disease, vasculitis or gastrointestinal bleeding within 3 months before screening.
- •There was a history of gastrointestinal perforation and/or fistula, a history of intestinal obstruction, and a history of inflammatory bowel disease within 6 months before screening.
- •Have a serious history of cardiovascular disease.
- •Symptomatic central nervous system metastasis.
- •Other malignant tumors confirmed and/or requiring treatment in the past 3 years.
- •Be suffering from infectious diseases.
- •Have an immune system disease or mental illness that requires treatment.
研究组 & 干预措施
Gentuximab Injection
Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.
干预措施: Gentuximab Injection (Drug)
Gentuximab Injection
Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.
干预措施: Gentuximab Injection Placebo (Drug)
Gentuximab Injection Placebo
Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.
干预措施: Gentuximab Injection (Drug)
Gentuximab Injection Placebo
Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days.
干预措施: Gentuximab Injection Placebo (Drug)
结局指标
主要结局
OS
时间窗: 36 months.
From date of randomization until the date of first documented death from any cause,assessed up to 36 months.
次要结局
- PFS(36 months.)
- TTF ORR DCR DOR(36 months. 36 months. 36 months. 36 months.)