NCT07079228招募中3 期
A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- Overall Suryival(OS)
研究概览
简要总结
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in the study and sign the informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival time ≥ 3 months;
- •Histologically or cytologically confirmed diagnosis of pancreatic cancer;
- •No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
- •At least one measurable lesion per RECIST v1.1;
- •Patients with adequate cardiac, liver, renal function, etc.
排除标准
- •History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- •Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- •Known central nervous system metastases;
- •Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- •Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
研究组 & 干预措施
QLS31905 + nab-paclitaxel + gemcitabine (AG)
Experimental
干预措施: QLS31905 (Drug)
QLS31905 + nab-paclitaxel + gemcitabine (AG)
Experimental
干预措施: Nab-paclitaxel. (Drug)
QLS31905 + nab-paclitaxel + gemcitabine (AG)
Experimental
干预措施: Gemcitabine (Drug)
Placebo + nab-paclitaxel + gemcitabine (AG)
Active Comparator
干预措施: Placebo for QLS31905 (Drug)
Placebo + nab-paclitaxel + gemcitabine (AG)
Active Comparator
干预措施: Nab-paclitaxel. (Drug)
Placebo + nab-paclitaxel + gemcitabine (AG)
Active Comparator
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Suryival(OS)
时间窗: Up to 48 months
OS is defined as the time from randomization to deathdue to any cause.
次要结局
- Progression Free Survival (PFS)(Up to 48 months)
- Objective Response Rate (ORR)(Up to 48 months)
- Duration Of Response (DOR)(Up to 48 months)
- Safety assessed by Adverse Events (AEs)(Up to 48 months)
研究者
研究点 (1)
Loading locations...
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