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

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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.

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