NCT07615907

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Aug 2027

First Submitted

Initial submission to the registry

April 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

April 22, 2026

Last Update Submit

May 25, 2026

Conditions

Gastric Cancer (GC)

Keywords

Gastric cancerSodium propionateImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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.

Study Arms (2)

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.

Dietary Supplement: Sodium propionate

Interventions

Sodium propionateDIETARY_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.

Also known as: Propionic acid
Sodium propionate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinying Wang

Nanjing, Jiangsu, 210002, China

Location

Related Publications (5)

  • 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.

    PMID: 32160527BACKGROUND

  • 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: 40715695BACKGROUND

  • 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: 32297948BACKGROUND

  • 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: 34443546BACKGROUND

  • 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: 40805185BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sodium propionatepropionic acid

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Xinying Wang, MD

CONTACT

+86 13913028866wangxinying@nju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 29, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)