Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Oesophagogastric Cancer

Официальное название

Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Phase II Trial

Обзор

The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Вмешательства

• Препарат Apatinib+Camrelizumab+SOX
  Apatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w
• Лучевая терапия Preoperative Radiotherapy
  Radiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred.

Первичные конечные точки

• Pathological Complete Response [Срок оценки: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment]

Вторичные конечные точки (8)

• Total Pathological Complete Response (tpCR) [Срок оценки: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment]
• Major pathological response(MPR) [Срок оценки: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment]
• Margin-free (R0) resection rate [Срок оценки: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment]
• Lymph node status after neoadjuvant therapy (ypN staging) [Срок оценки: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment]
• DFS [Срок оценки: up to 2 years]
• OS [Срок оценки: up to 2 years]
• Local control rate [Срок оценки: up to 2 years]
• AEs [Срок оценки: Up to approximately 18 months]

Критерии участия

Критерии включения

• Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
• Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Has adequate organ function.
• Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
• Has life expectancy of greater than 12 months.

Критерии исключения

• Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
• Known hypersensitivity to any of the study drugs or excipients.
• Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
• Congenital or acquired immune deficiency (e.g. HIV infected)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Публикации

• Li C, Tian Y, Zheng Y, Yuan F, Shi Z, Yang L, Chen H, Jiang L, Wang X, Zhao P, Zhang B, Wang Z, Zhao Q, Dong J, Lian C, Xu S, Zhang A, Zheng Z, Wang K, Dang C, Wu D, Chen J, Xue Y, Liang B, Cheng X, Wang Q, Chen L, Xia T, Liu H, Xu D, Zhuang J, Wu T, Zhao X, Wu W, Wang H, Peng J, Hou Z, Zheng R, Chen Y, Yin K, Zhu Z. Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceran PMID 39383487

Идентификаторы

NCT: NCT07026149 · 2024373

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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