The Efficacy and Safety of Iparomlimab/Tuvonralimab (Anti PD-1/CTLA-4) Combined With Albumin-bound Paclitaxel in Second-line Treatment of Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival（PFS）
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-paclitaxel in the second-line treatment of patients with advanced gastric/gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1. Can the combination of Iparomlimab/Tuvonralimab and albumin-paclitaxel for advanced gastric cancer/gastroesophageal junction cancer who has progressed or is intolerant to first-line SOC prolong the PFS and OS, improve ORR, DCR, and prolong DoR; 2. Whether Iparomlimab/Tuvonralimab ( anti PD-1/CTLA-4) combined with albumin-paclitaxel for second-line treatment remains effective for patients who have progressed from first-line PD-1±chemotherapy; 3. The safety and tolerability of Iparomlimab/Tuvonralimab in combination with albumin-paclitaxel for second-line treatment.Participants will:1. Use Iparomlimab/Tuvonralimab 5.0mg/kg, D1, Q3W; At least 30 minutes later, administer the chemotherapy albumin-paclitaxel: 260mg/m², D1, Q3W, and complete the infusion within 30 minutes. The combined regimen was administered every 3 weeks, with efficacy evaluated every 2 cycles (RECIST 1.1) until disease progression, intolerable toxicity or patient withdrawal.
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
- •Aged 18-75;
- •ECOG PS 0-2;
- •Histologically confirmed advanced of the gastric cancer/gastroesophageal junction adenocarcinoma;
- •Failure of first-line treatment: Progression or intolerance after receiving platinum-based (oxaliplatin/cisplatin) + fluorouracil (5-FU/ capecitabine /S-1) regimens;
- •The first-line use of PD-1 inhibitors is permitted;
- •At least one measurable lesion (RECIST v1.1);
- •Good organ function (ANC≥1.5×109/L, PLT≥100×109/L, with normal liver and kidney functions）.
排除标准
- •Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
- •Active autoimmune disease;
- •Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
研究组 & 干预措施
Iparomlimab and Tuvonralimab combined with albumin-paclitaxel
Iparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w
干预措施: Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel (Drug)
结局指标
主要结局
Progression-free survival（PFS）
时间窗: 3 years
Assessed by INV based on RECIST 1.1, defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first
次要结局
- Overall survival（OS）(4 years)
- Objective response rate（ORR）(3 years)
- Disease control rate（DCR）(3 years)
- Duration of Responce （DoR）(4 years)
- Adverse events(4 years)
研究者
Qingxia Li
Professor
Hebei General Hospital