Идёт набор NCT05360277

Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Фаза II С лечением Metastatic Colorectal Cancer，NED

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 + Capecitabine, Best supportive care.
Кому может быть актуально: Состояния в реестре: Metastatic Colorectal Cancer，NED. Базовые параметры: 18 лет — 80 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

Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease

Обзор

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

Подробное описание

This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.

Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.

Вмешательства

Препарат Tislelizumab + Capecitabine
Tislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.
Другое Best supportive care
Best supportive care

Первичные конечные точки

Disease-free survival [Срок оценки: 36 months]

Вторичные конечные точки (2)

Overall survival [Срок оценки: 60 months]
Adverse events [Срок оценки: 60 months]

Критерии участия

Критерии включения

Age ≥ 20 years, < 80 years
Written informed consent
Histologically or cytologically confirmed CRC
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
No previous chemotherapy
Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Adequate hematologic and organ function