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Идёт набор NCT06128252

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

Без фазы С лечением Gastric Cancer

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: Taurine, Serplulimab, XELOX regimen, Placebo.
Кому может быть актуально
Состояния в реестре: Gastric Cancer. 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

A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Обзор

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Вмешательства

  • Пищевая добавка Taurine
    Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
  • Биопрепарат Serplulimab
    Serplulimab
  • Препарат XELOX regimen
    Oxaliplatin + capecitabine
  • Пищевая добавка Placebo
    Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Первичные конечные точки

  • Pathological complete response [Срок оценки: Through study completion, Within 1 week after operation]
Вторичные конечные точки (10)
  • R0 resection rate [Срок оценки: Through study completion, Within 1 week after operation]
  • Major pathological response (MPR) [Срок оценки: Through study completion, Within 1 week after operation]
  • Objective response rate (ORR) [Срок оценки: Through study completion, an average of 1 year.]
  • Disease-free survival (DFS) [Срок оценки: Through study completion, an average of 1 year]
  • Event-free survival (EFS) [Срок оценки: Through study completion, an average of 1 year]
  • Overall survival (OS) [Срок оценки: Through study completion, an average of 1 year]
  • Quality of life [Срок оценки: Through study completion, an average of 1 year]]
  • Changes in CD8+ T cell infiltration in tumor tissue [Срок оценки: 1 year]
  • Changes in CD8+ T cell death and function [Срок оценки: Through study completion, an average of 1 year]
  • Safety endpoints [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Age 18-75 years old, no gender limitation;
  • Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
  • Expected survival of ≥ 3 months;
  • The tumor specimens were PD-L1 positive (CPS ≥ 1)；
  • There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Patients informed about the purpose and course of the study and provided a written consent to participate.

Критерии исключения

  • Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;
  • Patients with positive HER-2；
  • Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
  • Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
  • Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
  • There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 15 центров
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Ухань
  • Affiliated Drum Tower Hospital, Medical School of Nanjing University — Нанкин
  • The First Affiliated Hospital of China Medical University — Шэньян
  • Xi-jing Hospital — Сиань
  • Tang-Du Hospital — Сиань
  • Shaanxi Provincial People's Hospital — Сиань
  • Xi 'an International Medical Center Hospital — Сиань
  • The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) — Сиань
  • … и ещё 7 центров

Идентификаторы

NCT: NCT06128252 · K202308-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗