Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

Официальное название

Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach

Обзор

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

Вмешательства

• Препарат Perioperative treatment
  RC48+SOX+Sindilizumab

Первичные конечные точки

• pathological complete response rate [Срок оценки: within 10 days after surgery]

Вторичные конечные точки (5)

• major pathological response rate [Срок оценки: within 10 days after surgery]
• Objective response rate [Срок оценки: From enrollment to surgery, assessed up to 3 months]
• Event-free survival [Срок оценки: From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years]
• Disease free survival [Срок оценки: From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years]
• overall survival [Срок оценки: From date of diagnosis until the date of death from any cause, assessed up to 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Cancer Hospital & Institute — Пекин

Идентификаторы

NCT: NCT06992362 · LGH2024296

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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