Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
patients received placebo combined with anti-PD-1 therapy and chemotherapy, without additional sodium propionate intervention.
Eksperimentel: 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.
Kosttilskud: 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.
Andre navne:
  • Propionic acid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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).
up to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
up to 12 weeks
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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jinling Hospital, China

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. august 2027

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20260422

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mavekræft (GC)

Kliniske forsøg med Sodium propionate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner