Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Официальное название

Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Обзор

This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

Вмешательства

• Препарат Cadonilimab
  IV infusion,Specified dose on specified days
• Препарат AK117
  IV infusion,Specified dose on specified days
• Препарат Oxaliplatin
  IV infusion,Specified dose on specified days
• Препарат Tegafur-gimeracil-oteracil potassium
  Oral,Specified dose on specified days
• Препарат Docetaxel
  IV infusion,Specified dose on specified days
• Препарат 5-Fluorouracil
  IV infusion,Specified dose on specified days

Первичные конечные точки

• Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance [Срок оценки: Up to approximately 2 years]
• Pathological complete response (pCR) rates [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (9)

• Major pathological response(MPR) rates [Срок оценки: Up to approximately 2 years]
• Tumor regression grade(TRG) [Срок оценки: Up to approximately 2 years]
• R0 resection rate [Срок оценки: Up to approximately 2 years]
• Tumor descending stage rate [Срок оценки: Up to approximately 2 years]
• ORR [Срок оценки: Up to approximately 2 years]
• EFS [Срок оценки: Up to approximately 2 years]
• OS [Срок оценки: Up to approximately 2 years]
• PK [Срок оценки: Up to approximately 2 years]
• ADA [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Be able and willing to provide written informed consent.
• 18 to 75 years old.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
• Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\])
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Has adequate organ function.

Критерии исключения

• Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
• Is currently participating in a study of an investigational agent or using an investigational device.
• Has undergone major surgery within 30 days of Study Day 1.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
• History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Has received a live virus vaccine within 30 days of the planned first dose of study therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Provincial Tumor Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05960955 · AK104-219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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