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Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Recruiting
18-75 years
All
Phase 2

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Overview

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

Eligibility

Inclusion Criteria:

  • The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy;
  • HER2 negative (Immunohistochemistry: 0);
  • Patients with clinical stage II-III;
  • Those who are expected to complete R0 excision;
  • ECOG score 0\~1;
  • Generally in good condition, perioperative treatment and surgical resection can be tolerated;
  • Patients were enrolled voluntarily.

Exclusion Criteria:

  • Combined with other malignant tumors (excluding thyroid papillary carcinoma, facial basal cell carcinoma and other low-grade malignant tumors); -Patients with obstruction, bleeding, etc. who need surgical intervention after evaluation by clinicians;
  • dMMR/MSIH status;
  • Received other anti-tumor therapy before enrollment.

Study details
    Hepatoid Adenocarcinoma of Stomach

NCT07178340

Peking University Cancer Hospital & Institute

31 January 2026

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