Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Официальное название

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Обзор

To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1

Вмешательства

• Препарат Tislelizumab
  Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
• Препарат Oxaliplatin injection
  Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
• Препарат Levo-Leucovorin
  Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
• Препарат 5-fluorouracil
  5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
• Препарат Paclitaxel
  Paclitaxel will be administered on day 1 of each cycle at 135mg/m2

Первичные конечные точки

• progression free survival [Срок оценки: 4 years]

Вторичные конечные точки (2)

• Objective response rate [Срок оценки: every 4 weeks]
• Overall survival [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
• 18-70yeas.
• ECOG PS 0-1.
• No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy.
• With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
• Life expectancy ≥3 months.
• With normal electrocardiogram results and no history of congestive heart failure.
• With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
• Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.
• With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
• Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing.

Критерии исключения

• Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
• Patients with brain or central nervous system metastases, including leptomeningeal disease.
• Pregnant (positive pregnancy test) or breast feeding.
• Serious, non-healing wound, ulcer, or bone fracture.
• Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
• History of a stroke or CVA within 6 months.
• Clinically significant peripheral vascular disease.
• HIV-positive, active hepatitis B or C (HBV, HCV);
• Inability to comply with study and/or follow-up procedures.
• Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
• Her2-positive (IHC 3+ or 2+/FISH+) patients.

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: NCT06793917 · SYLT-030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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