Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma

Официальное название

Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study

Обзор

The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (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 ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma. Study Design: Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting. Participation Details: Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 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.

Подробное описание

To evaluate the efficacy and safety of ivonescimab in combination with S-1 and oxaliplatin (SOX) for the treatment of locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the neoadjuvant (perioperative) setting, with the goal of improving the pathological complete response (pCR) rate.

Вмешательства

• Препарат Ivonescimab (20mg/kg Q3W)
  ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .
• Препарат Oxaliplatin
  Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
• Препарат S-1
  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.

Первичные конечные точки

• Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination. [Срок оценки: Perioperative]

Вторичные конечные точки (9)

• Event-free survival (EFS) [Срок оценки: Through study completion,an average of 2 years]
• major pathologic response [Срок оценки: Perioperative]
• R0 resection [Срок оценки: Perioperative]
• overall survival (OS) [Срок оценки: Through study completion,an average of 2 years]
• disease-free survival (DFS) [Срок оценки: Through study completion,an average of 2 years]
• safety [Срок оценки: Through study completion,an average of 2 years]
• surgery-related complications [Срок оценки: Through study completion,an average of 2 years]
• An exploratory endpoint [Срок оценки: Through study completion,an average of 2 years]
• Quality of life [Срок оценки: Perioperative]

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 N+ M0 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

Китай · 1 центр

• West China Hospital, Sichuan University — Чэнду

Публикации

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• Tran-Minh ML, Lehmann-Che J, Lambert J, Theou-Anton N, Pote N, Dior M, Mary F, Goujon G, Gardair C, Schischmanoff O, Kaci R, Cucherousset N, Bertheau P, Couvelard A, Aparicio T; for NORDICAP. Prevalence and prognosis of microsatellite instability in oesogastric adenocarcinoma, NORDICAP 16-01. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101691. doi: 10.1016/j.clinre.2021.101691. Epub 2021 Apr 20 PMID 33852952

Идентификаторы

NCT: NCT07374250 · Huaxi gastric cancer · Huaxi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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