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Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

Study acronym: HASCHANGE01
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Lead sponsor: Peking University Cancer Hospital & Institute to Peking University Cancer Hospital & Institute
    • Eligibility criteria expanded, about 10 words
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 27, 2025 to May 20, 2025
    v3
  3. Start date: May 27, 2025 to Jun 27, 2025v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Disitamab Vedotin （RC48）, Oxaliplatin，Tegafur,Gimeracil and Oteracil Porassium Capsules （SOX）and Sindillimab works to treat locally advanced 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 RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach Participants will: * Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles
Trial Details
NCT Number NCT06992362
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