OncoMatch/Clinical Trials/NCT06826079
Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
Is NCT06826079 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Sorbitol for gastric junction adenocarcinoma.
Treatment: Sorbitol — 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number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first).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)..
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer
Disease stage
Required: Stage CT3-4N+M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: platinum-based chemotherapy
patients who have previously received platinum-based ... chemotherapy
Cannot have received: fluorouracil-based chemotherapy
patients who have previously received ... fluorouracil-based chemotherapy
Cannot have received: targeted therapy
patients who have previously received ... targeted therapy
Cannot have received: PD-1 antibody
patients who have previously received other PD-1 antibody treatment
Cannot have received: PD-1/PD-L1 immune therapy
patients who have previously received ... other PD-1/PD-L1 immune therapy
Lab requirements
Blood counts
HB ≥ 90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥ 125×10^9/L
Kidney function
serum Cr ≤ 1.25ULN or endogenous creatinine clearance rate > 50ml/min (Cockcroft-Gault formula)
Liver function
TBIL < 1.5ULN; ALT and AST < 2.5ULN, and for patients with liver metastasis, < 5ULN
Cardiac function
LVEF ≥ 50%; no uncontrolled hypertension, unstable angina, recent MI, or arrhythmia (QTcF: male ≥ 450 ms, female ≥ 470 ms)
Normal major organ function, meeting the following criteria: ... see full criteria above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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