A Study on the Efficacy of Sodium Propionate Combined With Anti-PD-1 Immunotherapy in Gastric Cancer

Официальное название

Sodium Propionate Combined With Anti-PD-1 Immunotherapy on Tumor Efficacy in Gastric Cancer Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• Response to treatment for gastric cancer [Срок оценки: up to 12 weeks]

Вторичные конечные точки (2)

• Tumor markers [Срок оценки: up to 12 weeks]
• Patient survival [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xinying Wang — Нанкин

Публикации

• Duscha A, Gisevius B, Hirschberg S, Yissachar N, Stangl GI, Dawin E, Bader V, Haase S, Kaisler J, David C, Schneider R, Troisi R, Zent D, Hegelmaier T, Dokalis N, Gerstein S, Del Mare-Roumani S, Amidror S, Staszewski O, Poschmann G, Stuhler K, Hirche F, Balogh A, Kempa S, Trager P, Zaiss MM, Holm JB, Massa MG, Nielsen HB, Faissner A, Lukas C, Gatermann SG, Scholz M, Przuntek H, Prinz M, Forslund S PMID 32160527
• Yu L, Guo Q, Gu X, Wang Z, Li J, Wang X, Xu Z, Wang Y, Zhang Y, Zhang Y, Ding Y, Chen Z, Chen K, Ding Y. Impact of gut microbiome on radiotherapy and immunotherapy efficacy in microsatellite-stable colorectal cancer: role of propionic acid and B. fragilis. Br J Cancer. 2025 Oct;133(7):956-969. doi: 10.1038/s41416-025-03105-2. Epub 2025 Jul 26. PMID 40715695
• Nomura M, Nagatomo R, Doi K, Shimizu J, Baba K, Saito T, Matsumoto S, Inoue K, Muto M. Association of Short-Chain Fatty Acids in the Gut Microbiome With Clinical Response to Treatment With Nivolumab or Pembrolizumab in Patients With Solid Cancer Tumors. JAMA Netw Open. 2020 Apr 1;3(4):e202895. doi: 10.1001/jamanetworkopen.2020.2895. PMID 32297948
• Pham CH, Lee JE, Yu J, Lee SH, Yu KR, Hong J, Cho N, Kim S, Kang D, Lee S, Yoo HM. Anticancer Effects of Propionic Acid Inducing Cell Death in Cervical Cancer Cells. Molecules. 2021 Aug 16;26(16):4951. doi: 10.3390/molecules26164951. PMID 34443546
• Eladwy RA, Fares M, Chang D, Alsherbiny MA, Li CG, Bhuyan DJ. Fuelling the Fight from the Gut: Short-Chain Fatty Acids and Dexamethasone Synergise to Suppress Gastric Cancer Cells. Cancers (Basel). 2025 Jul 28;17(15):2486. doi: 10.3390/cancers17152486. PMID 40805185

Идентификаторы

NCT: NCT07615907 · 20260422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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