NCT07178340招募中2 期
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative 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9月18日最近更新:
干预措施
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 albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative 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 albumin-bound paclitaxel combined with sintilimab and SOX in the treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach
- To evaluate the safety and long-term benefits of albumin-bound paclitaxel combined with sintilimab and SOX regimens in perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach
Participants will:
- Preoperative treatment with abumin-bound paclitaxel, SOX and sintilimab for 4 cycles
- Radical surgery after 4-6 weeks of the preoperative treatment
- Adjuvant treatment with albumin-bound paclitaxel, tegafur,gimeracil and oteracil porassium capsules and sintilimab 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
盲法说明
Masking Description
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 negative (Immunohistochemistry: 0);
- •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
干预措施: Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab. (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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