Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Официальное название

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

Обзор

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

Вмешательства

• Препарат Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.
  1. Neoadjuvant therapy for 4 cycles: albumin-bound paclitaxel 150mg/m2, intravenously, d1, a course of treatment every 21 days; sintilimab 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, twice a day, d1-14, every 21 days; oxaliplatin 85mg/m2, intravenously, d1, every 21 days. 2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant

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 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.

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: NCT07178340 · LGH2025138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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