A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 560
- 试验地点
- 64
- 主要终点
- Overall Survival (OS) in All Participants
研究概览
简要总结
This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine 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
- •Understood and signed an informed consent form.
- •Age ≥ 18 and ≤ 75 years old, male or female.
- •Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
- •Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
- •Willing to provide tissue for PD-L1 biomarker analysis.
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
- •Life expectancy ≥ 3 months.
- •Has adequate organ function.
- •Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
排除标准
- •Has squamous cell or undifferentiated gastric cancer.
- •Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
- •Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
- •Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has uncontrolled ascites, pleural effusion, or pericardial effusion.
- •Has active autoimmune disease that has required systemic treatment in past 2 years.
- •Has received a major surgery within 4 weeks prior to randomization.
- •Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
- •Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
- •Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
- •Has any serious and/or uncontrolled disease.
- •Has active viral infection.
- •Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- •Has participated in other anticancer drug clinical trials within 4 weeks.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
HX008 plus Irinotecan
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
干预措施: Irinotecan Hydrochloride Injection (Drug)
HX008 plus Irinotecan
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
干预措施: HX008 (Drug)
Placebo plus Irinotecan
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
干预措施: Irinotecan Hydrochloride Injection (Drug)
Placebo plus Irinotecan
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS) in All Participants
时间窗: Up to approximately 36 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
Overall Survival (OS) in Participants With PD-L1 CPS≥1
时间窗: Up to approximately 36 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.
次要结局
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 36 months)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 36 months)
- Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 36 months)
- Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 36 months)