SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer

Официальное название

A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Обзор

This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Подробное описание

This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.

Вмешательства

• Препарат SHR-1701
  SHR-1701, 1800mg, Q3w
• Препарат apatinib
  apatinib 250mg，Q3W
• Препарат S-1 & Oxaliplatin
  S-1, Oxaliplatin, Q3w

Первичные конечные точки

• Pathological Complete Response (pCR) [Срок оценки: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]

Вторичные конечные точки (7)

• Tumor Regression Grade (TRG) [Срок оценки: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
• ypN staging [Срок оценки: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
• R0 resection rate [Срок оценки: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
• Event free survival (EFS) [Срок оценки: Up to approximately 4 years]
• Disease-free survival (DFS) [Срок оценки: Up to approximately 4 years]
• Overall survival(OS) [Срок оценки: Up to approximately 4 years]
• AEs [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Patients voluntarily participate in this study and provide signed informed consent;
• Age ≥18 years old;
• Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
• Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
• No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
• Plan to proceed to surgery after completion of neoadjuvant therapy;
• Able to swallow tablets normally;
• Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Estimated life expectancy ≥12 months;
• Has adequate organ function.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.

Критерии исключения

• Known HER2 positive
• Need transthoracic surgical approach Based on the investigator's judgment
• Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;

5\. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07464756 · MA-GC-II-028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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