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Набор скоро начнётся NCT07097948

Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study Protocol Number: LungMate-033

Фаза II С лечением Postoperative Incidental Small Cell Lung Cancer Toripalimab Adjuvant Therapy Evaluation

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: Etoposide, Platinum, Toripalimab.
Кому может быть актуально
Состояния в реестре: Postoperative Incidental Small Cell Lung Cancer, Toripalimab Adjuvant Therapy Evaluation. Базовые параметры: от 18 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

Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study

Обзор

Small cell lung cancer (SCLC) is highly malignant and aggressive, with most patients presenting with metastases at diagnosis. For postoperatively incidentally detected SCLC (identified unexpectedly in pathological examinations after surgery), conventional adjuvant chemoradiotherapy has shown limited efficacy, characterized by high recurrence rates and suboptimal long-term survival.Notably, advances in immunotherapy have transformed SCLC management. The EXTENTORCH trial, a pivotal study published in JAMA Oncology, demonstrated that toripalimab plus chemotherapy significantly improved outcomes in extensive-stage SCLC (ES-SCLC), achieving a reduced risk of progression or death (HR=0.67, 95% CI 0.54-0.82, P\<0.001) with manageable safety, marking a substantial therapeutic breakthrough. Given the proven efficacy of toripalimab in ES-SCLC, there is a strong rationale to extend this strategy to postoperatively incidentally detected SCLC. This trial aims to evaluate the efficacy and safety of toripalimab as adjuvant maintenance therapy in this cohort, with the objective of reducing recurrence and enhancing long-term survival.

Вмешательства

  • Препарат Etoposide
    Specified dose on specified days.
  • Препарат Platinum
    Specified dose on specified days.
  • Препарат Toripalimab
    Specified dose on specified days.

Первичные конечные точки

  • Disease-Free Survival (DFS) [Срок оценки: up to 60 months]
Вторичные конечные точки (4)
  • Overall Survival (OS) [Срок оценки: up to 60 months]
  • Health related quality of life (HRQol)：EORTC-QLQ-C30 [Срок оценки: up to 5 months]
  • Health related quality of life (HRQol)：LC13 [Срок оценки: up to 5 months]
  • Treatment-related adverse event (TRAE) [Срок оценки: Up to 30 months]

Критерии участия

Критерии включения

  • The patient shall sign the Informed Consent Form;
  • Aged ≥ 18 years;
  • Patients with definitely incidental SCLC confirmed by pathological results after radical resection of lung cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Life expectancy is at least 12 weeks;
  • Good function of other major organs (liver, kidney, hematological system, etc.);
  • Fertile female patients must undergo a pregnancy test within 7 days before the start of treatment with a negative result; and reliable contraceptive measures (such as intrauterine devices, contraceptives and condoms) should be used during the trial and within 30 days after its completion;
  • Fertile male subjects must use condoms for contraception during the trial and within 30 days after its completion.

Критерии исключения

  • Patients with a malignancy other than SCLC within five years prior to the start of this trial;
  • Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
  • With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  • Participants who are allergic to the test drug or any auxiliary materials;
  • Participants with active hepatitis B, hepatitis C or HIV;
  • Participants with Interstitial lung disease currently;
  • Pregnant or lactating women;
  • Any malabsorption;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
  • Other factors that researchers think it is not suitable for enrollment.

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
  • Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07097948 · LungMate-033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗