RecruitingPhase 2Phase 3NCT06826079

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

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


Sponsor

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

Enrollment

80 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 placebo (a look-alike substance that contains no drug) to see if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. . Participants will: Take sorbitol or a placebo 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number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first).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)..


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding sorbitol (a sugar alcohol sometimes used as a laxative and for other medical purposes) to standard neoadjuvant chemotherapy (chemo given before surgery) improves outcomes for people with certain cancers. **You may be eligible if...** - You are 18 or older - You have a cancer type being treated with neoadjuvant chemotherapy before surgery - You have not yet started chemotherapy for this cancer - Your organ function is within acceptable ranges **You may NOT be eligible if...** - You have hereditary fructose intolerance or sorbitol intolerance - You have severe diabetes (sorbitol can affect blood sugar) - You have active serious infections - You are pregnant or breastfeeding - You have had prior chemotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSorbitol

During the neoadjuvant treatment week, oral sorbitol 2-4g/ time, three times a day (with meals)

OTHERPlacebo

During the neoadjuvant treatment week, oral placebo 2-4g/ time, three times a day (with meals)


Locations(1)

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

Wuhan, Hubei, China

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NCT06826079


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