Health TrialsbyHealthPanel

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

ConditionGastric Cancer (GC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJinling Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium propionate

    Dietary 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Sodium propionateExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
up to 12 weeks

Secondary outcomes

1

Tumor markers

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.

Time frame
up to 12 weeks
2

Patient survival

Follow up on the survival status of patients

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinling Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: