Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- R0 surgical conversion rate
研究概览
简要总结
This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.
详细描述
Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
- •Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.
- •Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma
- •At least one measurable tumor lesion per RECIST v1.1;
- •Major organ functions are adequate;
- •Expected survival is ≥ 3 months;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;
排除标准
- •Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;
- •Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors;
- •Central nervous system, lung, or bone metastases;
- •Known history of active or autoimmune disease;
- •Known history of other malignancies;
- •Known history of severe cardiovascular and cerebrovascular diseases;
- •Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;
- •Active infection or fever of unknown origin;
- •Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
- •Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;
- •Known history of mental disorder or psychoactive substance abuse;
- •Hypersensitivity to the drugs of this regimen;
研究组 & 干预措施
AK104 plus apatinib, paclitaxel and S-1
AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.
干预措施: AK104 (Drug)
AK104 plus apatinib, paclitaxel and S-1
AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.
干预措施: Apatinib (Drug)
AK104 plus apatinib, paclitaxel and S-1
AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.
干预措施: Paclitaxel (Drug)
AK104 plus apatinib, paclitaxel and S-1
AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.
干预措施: S-1 (Drug)
结局指标
主要结局
R0 surgical conversion rate
时间窗: up to 2 years
次要结局
- R0 resection rate(up to 2 years)
- Pathological complete response (pCR)(up to 2 years)
- Pathological major response (MPR)(up to 2 years)
- Objective response rate (ORR)(up to 2 years)
- Disease control rate (DCR)(up to 2 years)
- Progression-free survival (PFS)(up to 2 years)
- Adverse event (AE)(up to 2 years)