Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma

Официальное название

Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study

Обзор

The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen. Primary Objective: To determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma. Study Design: Participants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting. Participation Details: Participants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months. They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring. Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.

Вмешательства

• Препарат fruquintinib + sintilimab + SOX
  Fruquintinib, 4mg po d1-14 q3w, four 3-week cycles were administered; S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: \<1.25 m², 80 mg/day; ≥1.25 to \<1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered. Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
• Препарат Sinitilimab+SOX
  S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: \<1.25 m², 80 mg/day; ≥1.25 to \<1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered. Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.

Первичные конечные точки

• Total pathological complete response (pCR) [Срок оценки: Perioperative]

Вторичные конечные точки (9)

• Event-free survival (EFS) [Срок оценки: Through study completion, an average of 2 years]
• TRAEs [Срок оценки: Through study completion,an average of 2 years]
• major pathologic response（MPR) [Срок оценки: Perioperative]
• R0 resection [Срок оценки: Perioperative]
• overall survival (OS) [Срок оценки: Through study completion,an average of 2 years]
• Expression of Predictive Biomarkers Associated With Treatment Response [Срок оценки: Baseline through study completion, an average of 2 years]
• Change in Quality of Life Assessed by EORTC QLQ-C30 [Срок оценки: Through study completion, an average of 2 years]
• disease-free survival (DFS) [Срок оценки: From date of post-surgery until the date of first occurrence of relapse, metastasis, or date of death from any cause, whichever came first, assessed up to 100 months]
• Change in Quality of Life Assessed by EORTC QLQ-STO22 [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Age 18-75 years.
• Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
• Considered eligible for curative resection.
• No prior antitumor therapy for the current disease.
• Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
• Expected survival of ≥6 months.

Критерии исключения

• Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
• Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
• Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
• History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
• Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07658872 · HUAXI-GC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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