Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

Официальное название

Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)

Обзор

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.

Вмешательства

• Препарат Tislelizumab
  Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
• Препарат apatinib
  Participants will receive apatinib, 250mg, qd，every 3 weeks for 3 weeks
• Препарат oxaliplatin
  Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
• Препарат S-1
  Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.

Первичные конечные точки

• Pathological complete response [Срок оценки: 4 weeks after surgery]

Вторичные конечные точки (2)

• Major pathological response [Срок оценки: 4 weeks after surgery]
• Objective Response Rate (ORR) [Срок оценки: At the end of Cycle 3 (each cycle is 21 days)]]

Критерии участия

Критерии включения

• Age: 18-70 years of age.
• Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume >5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8.
• Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
• ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
• No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
• Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
• The expected survival time is more than 6 months.
• For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.

Критерии исключения

• Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
• Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required.
• Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
• A history of immunodeficiency, including HIV testing positive.
• Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
• Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
• HER2 positive is known.
• Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.

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

• Fujian cancer hospital — Фучжоу

Идентификаторы

NCT: NCT05699655 · TAOS-3B Trial 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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