NCT06341335招募中3 期
A Randomized, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy
Akeso1 个研究点 分布在 1 个国家目标入组 506 人开始时间: 2024年6月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by blinded independent central review (BICR)
研究概览
简要总结
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
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
- •Signed informed consent
- •Age ≥ 18 years and ≤ 75 years
- •Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- •Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
- •At least one measurable disease based on RECIST v1.1
- •ECOG status of 0 or 1
- •Estimated survival ≥ 3 months
- •Adequate organ function per protocol-defined criteria
- •Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
排除标准
- •Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
- •HER2-positive
- •Known other invasive malignancies within 3 years
- •Subjects who are currently participating in other interventional study
- •Received prior systemic anti-tumour therapy within 4 weeks before randomization
- •Previous systemic treatment with taxane within 6 months before randomization
- •Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
- •In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
- •History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
- •History of severe infection within 4 weeks prior to randomization
- •Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- •History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
- •Major surgical procedure or serious trauma within 28 days prior to randomization
- •History of interstitial lung disease or noninfectious pneumonitis
- •Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
- •Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
- •History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
- •Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
- •Use of live vaccines within 30 days prior to randomization
- •Pregnant or lactating women.
- •Any condition considered by the investigator to be inappropriate for enrollment
研究组 & 干预措施
Placebo in combination with paclitaxel
Active Comparator
Placebo in combination with Paclitaxel, iv, every 3 weeks
干预措施: paclitaxel (Drug)
Cadonilimab in combination with pulocimab and paclitaxel
Experimental
Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks
干预措施: cadonilimab (Drug)
Cadonilimab in combination with pulocimab and paclitaxel
Experimental
Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks
干预措施: pulocimab (Drug)
Cadonilimab in combination with pulocimab and paclitaxel
Experimental
Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks
干预措施: paclitaxel (Drug)
Placebo in combination with paclitaxel
Active Comparator
Placebo in combination with Paclitaxel, iv, every 3 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by blinded independent central review (BICR)
时间窗: Up to 2 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Overall survival (OS)
时间窗: Up to 2 years
OS is defined as the time from randomization to death due to any cause.
次要结局
- Progression-free survival (PFS) assessed by investigator(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Duration of Response (DoR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
研究者
研究点 (1)
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