Actively Recruiting
Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-09-09
80
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first).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)..
CONDITIONS
Official Title
Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Written informed consent obtained
- Histologically confirmed, untreated HER2-negative gastric or gastroesophageal junction adenocarcinoma with clinical stage cT3-4N+M0
- Siewert type II or III gastroesophageal junction cancer not requiring combined thoracotomy
- ECOG performance status score of 0 or 1
- Normal major organ function with specific blood and biochemical test results
- Fertile women must use reliable contraception or have a negative pregnancy test within 7 days before enrollment and agree to contraception during and 8 weeks after treatment
- Men must agree to use contraception during and 8 weeks after treatment or have undergone surgical sterilization
You will not qualify if you...
- Presence of distant organ or peritoneal metastasis
- Active or recorded autoimmune or inflammatory diseases except controlled celiac disease
- Other active malignant tumors within 5 years except certain cured localized tumors
- Previous or planned organ or bone marrow transplantation
- Uncontrolled infections or cardiovascular diseases including unstable angina or heart failure
- Use of immunosuppressants or systemic/local hormones for immunosuppression within 2 weeks before enrollment
- Prior platinum-based, fluorouracil-based chemotherapy, targeted therapy, PD-1/PD-L1 therapy, or radiotherapy to target lesions
- Conditions affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction)
- Recent significant bleeding or bleeding tendency
- Poorly controlled hypertension or serious arrhythmia
- Significant proteinuria or abnormal coagulation function
- Recent thrombotic events within the past year
- History of psychotropic drug abuse or mental disorders
- Serious concomitant diseases affecting safety or study completion
- Pregnant or lactating women
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Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 470000
Actively Recruiting
Research Team
Y
Yao Lin, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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