- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07615907
A Study on the Efficacy of Sodium Propionate Combined With Anti-PD-1 Immunotherapy in Gastric Cancer (PAPGC)
25 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xinying Wang, MD
- Telefonnummer: +86 13913028866
- E-post: wangxinying@nju.edu.cn
Studieorter
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210002
- Xinying Wang
-
Kontakt:
- Xinying Wang, MD
- Telefonnummer: +86 13913028866
- E-post: wangxinying@nju.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control
patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention.
|
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Response to treatment for gastric cancer
Tidsram: 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).
|
up to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor markers
Tidsram: 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
|
|
Patient survival
Tidsram: 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.
|
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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 maj 2026
Primärt slutförande (Beräknad)
30 augusti 2026
Avslutad studie (Beräknad)
30 augusti 2027
Studieregistreringsdatum
Först inskickad
22 april 2026
Först inskickad som uppfyllde QC-kriterierna
25 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260422
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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