NCT06992362招募中2 期
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月20日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pathological complete response rate
研究概览
简要总结
The goal of this clinical trial is to learn if treatment modality including Disitamab Vedotin （RC48）, Oxaliplatin，Tegafur,Gimeracil and Oteracil Porassium Capsules （SOX）and Sindillimab works to treat locally advanced hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are:
- To evaluate the perioperative efficacy of RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach
- To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach
Participants will:
- Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles
- Radical surgery after 4-6 weeks of the preoperative treatment
- Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles
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
- •The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy；
- •HER2 expression (Immunohistochemistry: 1+,2+,3+);
- •Patients with clinical stage II-III;
- •Those who are expected to complete R0 excision;
- •ECOG score 0~1;
- •Generally in good condition, perioperative treatment and surgical resection can be tolerated;
- •Patients were enrolled voluntarily.
排除标准
- •Combined with other malignant tumors (excluding thyroid papillary carcinoma, facial basal cell carcinoma and other low-grade malignant tumors); -Patients with obstruction, bleeding, etc. who need surgical intervention after evaluation by clinicians;
- •dMMR/MSIH status；
- •Received other anti-tumor therapy before enrollment.
研究组 & 干预措施
perioperative treatment for hepatoid adenocarcinoma of stomach
Experimental
- Neoadjuvant therapy: Disitamab Vedotin 2.5mg/kg, d1, a course of treatment every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium Capsules (by body surface area: BSA<1.25m2, 40mg; BSA≥1.25m2, <1.5m2, 50mg; BSA≥1.5m2,60mg), orally, twice a day, d1-14, every 21 days; Oxaliplatin 85mg/m2, IV, d1, every 21 days.
- Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy.
- Adjuvant therapy: Adjuvant therapy begins within 4-6 weeks after surgery. Disitamab Vedotin 2.5mg/kg intravenously, d1, one course every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium (by body surface area:BSA<1.25m2, 40mg; BSA≥1.25m2, <1.5m2, 50mg; BSA≥1.5m2,60mg) orally, 2 times daily, d1-14, one course every 21 days.
干预措施: Perioperative treatment (Drug)
结局指标
主要结局
pathological complete response rate
时间窗: within 10 days after surgery
The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects
次要结局
- major pathological response rate(within 10 days after surgery)
- Objective response rate(From enrollment to surgery, assessed up to 3 months)
- Event-free survival(From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years)
- Disease free survival(From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years)
- overall survival(From date of diagnosis until the date of death from any cause, assessed up to 3 years)
研究者
研究点 (1)
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