Sodium Propionate Combined With Anti-PD-1 Immunotherapy on Tumor Efficacy in Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Response to treatment for gastric cancer
研究概览
简要总结
Eligible patients were randomized into two groups: the sodium propionate group and the control group. In the control group, patients received placebo combined with anti-PD-1 therapy plus chemotherapy without additional sodium propionate intervention. In the sodium propionate group, on the basis of anti-PD-1 therapy combined with chemotherapy, patients were additionally administered oral sodium propionate capsules at a dose of 500 mg (1 capsule) twice weekly, with a total intervention duration of 12 weeks. The primary and secondary outcome indicators will be collected for subsequent analysis.
详细描述
Eligible patients with unresectable gastric cancer were randomly assigned to either the sodium propionate group or the control group. In the control group, patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention. In the sodium propionate group, on the basis of anti-PD-1 therapy combined with chemotherapy, patients were additionally given oral sodium propionate capsules at a dose of 500 mg per capsule, one capsule twice a week, for a total intervention period of 12 weeks. Relevant primary and secondary outcome measures will be collected for further analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participated in the trial and signed the informed consent form;
- •Aged ≥ 18 years and < 80 years, regardless of gender;
- •Stable vital signs;
- •Patients with gastric adenocarcinoma confirmed by gastroscopic biopsy;
- •Tumors judged as unresectable by attending physicians;
- •Receiving anti-PD-1 therapy combined with chemotherapy as first-line treatment;
- •No history of allergic diseases and non-allergic constitution;
- •No history of drug abuse;
- •Non-pregnant and non-lactating females (applicable to male subjects as well);
- •No participation in any drug clinical trial (including investigational drugs of this trial) within 3 months prior to enrollment.
排除标准
- •Failure to meet the inclusion criteria, or individuals deemed inappropriate for trial participation by investigators;
- •Concurrent primary malignant tumors at other sites;
- •Poor general condition, severe infection, respiratory insufficiency, or other conditions leading to inability to cooperate with the trial;
- •Patients with mental disorders, consciousness disturbance, or poor treatment compliance;
- •Suspected or confirmed history of drug abuse;
- •Immunodeficiency, or long-term use of immunosuppressants and glucocorticoids;
- •Pregnant or lactating women;
- •Sponsors, investigators directly involved in this trial, and their immediate family members;
- •Individuals unsuitable for enrollment for any reason as judged by the investigator.
研究组 & 干预措施
Control
patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention.
Sodium propionate
on the basis of anti-PD-1 therapy combined with chemotherapy, patients were additionally given oral sodium propionate capsules at a dose of 500 mg per capsule, one capsule twice a week, for a total intervention period of 12 weeks.
干预措施: Sodium propionate (Dietary Supplement)
结局指标
主要结局
Response to treatment for gastric cancer
时间窗: up to 12 weeks
Tumor responses in patients with gastric cancer after corresponding treatment were evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
次要结局
- Tumor markers(up to 12 weeks)
- Patient survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)
研究者
Wang Xinying
prof
Jinling Hospital, China