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RECRUITING
NCT06826079
PHASE2

Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are: Does sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer? Researchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. Participants will: Take sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).

Official title: Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2024-11-01

Completion Date

2029-08-01

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Sorbitol + PD-1 inhibitor + SOX chemotherapy

PD-1 inhibitor + SOX chemotherapy. During the neoadjuvant treatment week, oral sorbitol 2-4g/ time, three times a day (with meals)

DRUG

PD-1 inhibitor + SOX chemotherapy

PD-1 inhibitor + SOX chemotherapy

Locations (1)

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China