Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06826079 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: SNCCTGC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 1, 2026 → Aug 1, 2028
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Record History

  1. Primary completion pushed from Aug 1, 2026 to Aug 1, 2028 Primary endpoint(s) modified · Phase changed: Phase 2/3 → Phase 2 · Completion pushed from Aug 1, 2028 to Aug 1, 2029 · 4 morev5 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 2/3 → Phase 2
    • Completion pushed from Aug 1, 2028 to Aug 1, 2029
    • Enrollment target: 80 to 86
    • Interventions: Placebo (Other), Sorbitol (Drug) to PD-1 inhibitor + SOX chemotherapy (Drug), Sorbitol + PD-1 inhibitor + SOX chemotherapy (Drug)
    • Secondary endpoints: 2 to 4
    • Study description shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Aug 1, 2025 to Aug 1, 2026v4
  3. Trial status: Active, Not Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  4. Eligibility criteria shortened, about 9 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06826079
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Gastric Junction Adenocarcinoma, Gastric Cancer, Immunotherapy, Neoadjuvant Therapies
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov