A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Официальное название

A Randomized, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Обзор

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Вмешательства

• Препарат AK104(SC)
  AK104:subcutaneous injection
• Препарат AK104(IV)
  AK104:intravenous
• Препарат Capecitabine
  oral
• Препарат Oxaliplatin injection
  intravenous

Первичные конечные точки

• Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2). [Срок оценки: up to 4 weeks]
• Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration. [Срок оценки: up to 4 weeks]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) per RECIST 1.1 [Срок оценки: up to 24 months]
• Disease Control Rate (DCR) per RECIST 1.1 [Срок оценки: Up to 24 months]
• Progression-free survival (PFS) assessed by investigator per RECIST v1.1 [Срок оценки: Up to 24 months]
• Duration of Response (DOR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to 24 months]
• Time to Response (TTR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to 24 months]
• Overall Survival [Срок оценки: Up to 24 months]
• Number of participants with adverse event (AE) [Срок оценки: Up to 27 months]

Критерии участия

Критерии включения

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
• Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
• Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
• Adequate organ and bone marrow function.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Measurable disease by RECIST 1.1.

Критерии исключения

• Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.
• Deep venous thrombosis within 3 months before first treatment.
• Uncontrolled arterial hypertension.
• Bleeding events within the last 1 months.
• Prior treatment with immune checkpoint inhibitors.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

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: NCT07449780 · AK104-SC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗