Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach

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

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.