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 (Jun 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number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first).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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06826079 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT3-4N+M0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages