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Идёт набор NCT07198217

Real World Study of Platinum Containing Dual Drug Chemotherapy Followed by Large Fractionated Radiotherapy Combined withTislelizumab in Stage IIIB/C-IV Non-small Cell Lung Cancer Patient

Фаза II С лечением NSCLC Tislelizumab Chemotherapy Hypofractionated Radiotherapy

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: SBRT combined with Tislelizumab followed by Tislelizumab.
Кому может быть актуально
Состояния в реестре: NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy. 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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Обзор

In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.

Вмешательства

  • Препарат SBRT combined with Tislelizumab followed by Tislelizumab
    The enrolled population consists of patients with stage IIIB/C-IV non-small cell lung cancer who are driver gene negative or unknown, as well as those with driver gene positive targeted drug resistance. The patients reaching SD, PR, or CR after 4 cycles of platinum based dual drug chemotherapy. The patient will receive SBRT radiotherapy combined with Tislelizumab treatment, followed by Tislelizumab maintenance therapy.

Первичные конечные точки

  • One-year PFS rate [Срок оценки: Up to approximately 24 months]
Вторичные конечные точки (5)
  • Progression-Free Survival (PFS) [Срок оценки: Up to approximately 30 months]
  • Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
  • Overall survival (OS) [Срок оценки: Up to ~48 months]
  • Disease Control Rate (DCR) [Срок оценки: Up to ~24 months]
  • Adverse events [Срок оценки: Through study completion, an average of 2 year]

Критерии участия

Критерии включения

  • Age 18-75 years old, gender is not limited;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
  • Tumor histology or hematology confirms no EGFR mutations and no mutations or positive driver genes for ALK, BRAF, ROS1, RET, MET, etc or Targeted drug therapy leads to drug resistance progression

Критерии исключения

  • Patients with uncontrolled autoimmune diseases;
  • Patients who have experienced autoimmune reactions within the past 6 months and whose conditions have not improved or are unstable after corresponding treatments, such as pneumonia, thyroiditis, myocarditis, etc. that have not stabilized after treatment;
  • Patients who have previously received systemic chemotherapy, or adjuvant or neoadjuvant therapy, and the time from the last treatment to recurrence is less than 3 months;
  • Patients with known allergies or contraindications to the study drug or its excipients;
  • Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
  • Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
  • Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.

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
  • Zibo Municipal Hospital — Zibo

Идентификаторы

NCT: NCT07198217 · 2021-Ethical Review -01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗