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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention. | |
| Sodium propionate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium propionate | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment for gastric cancer | 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). | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor markers | Serum levels of CEA in ng/mL, CA19-9 in U/mL, CA72-4 in U/mL, AFP in ng/mL and CA125 in U/mL were routinely measured in patients on a monthly basis. | up to 12 weeks |
| Patient survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinying Wang, MD | Contact | +86 13913028866 | wangxinying@nju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinying Wang | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32160527 | Background | 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 SK, Winklhofer KF, Muller DN, Linker RA, Gold R, Haghikia A. Propionic Acid Shapes the Multiple Sclerosis Disease Course by an Immunomodulatory Mechanism. Cell. 2020 Mar 19;180(6):1067-1080.e16. doi: 10.1016/j.cell.2020.02.035. Epub 2020 Mar 10. | |
| 40715695 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C514135 | sodium propionate |
| C029658 | propionic acid |
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|
Follow up on the survival status of patients
| 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. |
| Background |
| 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. |
| 32297948 | Background | 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. |
| 34443546 | Background | 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. |
| 40805185 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |