Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach (HASCHANGE01)

Peking University Cancer Hospital & Institute

Status and phase: Enrolling; Phase 2

Conditions: Hepatoid Adenocarcinoma of Stomach

Treatments: Drug: Perioperative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06992362

LGH2024296

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy；
• HER2 expression (Immunohistochemistry: 1+,2+,3+);
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

perioperative treatment for hepatoid adenocarcinoma of stomach

Experimental group

Description:

1. Neoadjuvant therapy: Disitamab Vedotin 2.5mg/kg, d1, a course of treatment every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium Capsules (by body surface area: BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg), orally, twice a day, d1-14, every 21 days; Oxaliplatin 85mg/m2, IV, d1, every 21 days. 2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy. 3. Adjuvant therapy: Adjuvant therapy begins within 4-6 weeks after surgery. Disitamab Vedotin 2.5mg/kg intravenously, d1, one course every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium (by body surface area:BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg) orally, 2 times daily, d1-14, one course every 21 days.

Treatment:

Drug: Perioperative treatment