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Набор скоро начнётся NCT06396585

The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction

Фаза II С лечением Immunotherapy Gastroesophageal Junction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tislelizumab, Anlotinib, Oxaliplatin, Tegafur.
Кому может быть актуально
Состояния в реестре: Immunotherapy Gastroesophageal Junction. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction : a Prospective，Single-arm, Phase II Trial (TASTE Trial)

Обзор

To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer

Вмешательства

  • Препарат Tislelizumab
    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W
  • Препарат Anlotinib
    Participants will receive anlotinib,12mg, qd，d1-d14，Q3W
  • Препарат Oxaliplatin
    Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W
  • Препарат Tegafur
    Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W

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

  • Female and male patient ≥ 18 and ≤ 75 years.
  • Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient
  • ECOG≤1
  • No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
  • Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs).
  • Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
  • The expected survival time is more than 6 months.
  • Women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study.
  • Hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy
  • Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures

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
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Fujian cancer hospital — Фучжоу

Идентификаторы

NCT: NCT06396585 · TASTE Trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗