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Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Study acronym: HASCHANGE02
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 20, 2025 to Sep 18, 2025
    • Interventions: Perioperative treatment (Drug) to Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab. (Drug)
    • Site details revised
    • Study title shortened, about 2 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treatment modality including albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are: * To evaluate the perioperative efficacy of albumin-bound paclitaxel combined with sintilimab and SOX in the treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of albumin-bound paclitaxel combined with sintilimab and SOX regimens in perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach Participants will: * Preoperative treatment with abumin-bound paclitaxel, SOX and sintilimab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with albumin-bound paclitaxel, tegafur,gimeracil and oteracil porassium capsules and sintilimab for 4 cycles
Trial Details
NCT Number NCT07178340
Lead Sponsor Peking University Cancer Hospital & Institute
Conditions
(from sponsor)
Hepatoid Adenocarcinoma of Stomach
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov