- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07615907
A Study on the Efficacy of Sodium Propionate Combined With Anti-PD-1 Immunotherapy in Gastric Cancer (PAPGC)
25. mai 2026 oppdatert av: Wang Xinying, Jinling Hospital, China
Sodium Propionate Combined With Anti-PD-1 Immunotherapy on Tumor Efficacy in Gastric Cancer Patients
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xinying Wang, MD
- Telefonnummer: +86 13913028866
- E-post: wangxinying@nju.edu.cn
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210002
- Xinying Wang
-
Ta kontakt med:
- Xinying Wang, MD
- Telefonnummer: +86 13913028866
- E-post: wangxinying@nju.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention.
|
|
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Eksperimentell: 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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Response to treatment for gastric cancer
Tidsramme: 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).
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up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tumor markers
Tidsramme: up to 12 weeks
|
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.
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up to 12 weeks
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Patient survival
Tidsramme: 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.
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Follow up on the survival status of patients
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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.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. mai 2026
Primær fullføring (Antatt)
30. august 2026
Studiet fullført (Antatt)
30. august 2027
Datoer for studieregistrering
Først innsendt
22. april 2026
Først innsendt som oppfylte QC-kriteriene
25. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20260422
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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