Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Официальное название

A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Обзор

This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.

Вмешательства

• Препарат tegafur, Gimeracil and Oteracil Potassium Capsules
  40mg/m2, D1-14 BID PO Q3W
• Препарат Sintilimab Placebo
  200 mg, D1 IV Q3W
• Препарат Sintilimab
  200mg D1 IV Q3W
• Препарат Ipilimumab N01
  1mg/kg, D1 IV Q6W
• Препарат Oxaliplatin for injection
  130 mg/m2 D1 IV Q3W
• Препарат Ipilimumab N01 Placebo
  1mg/kg, D1 IV Q6W

Первичные конечные точки

• Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma [Срок оценки: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
• Event-Free Survival (EFS) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (6)

• pathological Complete Response (pCR) rate [Срок оценки: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
• Clinical Down-staging Rate [Срок оценки: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
• R0 resection rate [Срок оценки: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )]
• Overall survival (OS) [Срок оценки: Up to approximately 5 years]
• numbers of subjects with adverse events [Срок оценки: Up to approximately 5 years]
• numbers of subjects with serious adverse events [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

• Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival ≥ 6 months.
• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
• Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
• Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.

Критерии исключения

• Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
• Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
• History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
• Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
• Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
• Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
• Active uncontrolled bleeding or known bleeding diathesis.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07643623 · CIBI310M301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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