A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

Официальное название

A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Обзор

This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

Подробное описание

This trial is a Phase 3 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 for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.

Вмешательства

• Препарат Cadonilimab
  Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
• Препарат SOX chemotherapy
  A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
• Препарат Placebo
  Placebo

Первичные конечные точки

• Event-free survival (EFS) [Срок оценки: Up to 5 years]
• Pathological Complete Response (pathCR) Rate [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (3)

• Overall survival (OS) [Срок оценки: Up to 10 years]
• Disease-free Survival (DFS) [Срок оценки: Up to 5 years]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Has life expectancy of at least 6 months.
• Availability of tumor sample prior to study entry.
• Patients must undergo radical surgery.
• Has adequate organ function.

Критерии исключения

• Patients with unresectable locally advanced disease or distant metastasis.
• Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
• Current or prior use of immunosuppressive medication within 14 days before randomization.
• Has received prior anti-cancer therapy for the current malignancy.
• Has an active infection requiring systemic therapy.
• Contra-indication to any of the study drugs.
• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Known active Hepatitis B or Hepatitis C virus infection.
• Has had an allogenic tissue/solid organ transplant.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Peking University Cancer Hospital — Пекин
• Fujian Provincial Cancer Hospital — Фучжоу
• Fourth Hospital of Hebei Medical University — Shijiazhuang
• Harbin Medical University Cancer Hospital — Харбин
• Zhongshan Hospital, Fudan University — Шанхай
• Tianjin Provincial Tumor Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07023315 · AK104-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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