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Идёт набор NCT07085169

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Фаза II С лечением Colo-rectal Cancer Third-line and Beyond Therapy TAS 102 Bevacizumab

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: Trifluridine/tipiracil (TAS-102) plus bevacizumab.
Кому может быть актуально
Состояния в реестре: Colo-rectal Cancer, Third-line and Beyond Therapy, TAS 102, Bevacizumab. Базовые параметры: от 60 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
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Официальное название

Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study

Обзор

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Подробное описание

The treatment options as third-line therapy for metastatic colorectal cancer patients are limited. Trifluridine/tipiracil (TAS-102) plus bevacizumab has been approved in colorectal cancer for patients who are refractory to or intolerant of standard chemotherapy. However, the toxicity of trifluridine/tipiracil at standard dose a clinical concerned issue. Modifications of dose and treatment cycle of trifluridine/tipiracil have been investigated, and show promising effect to reduce the toxicity. In this study, patients with refractory metastatic colorectal cancer who have disease progression after at least 2 standard regimens will be treated with low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Вмешательства

  • Препарат Trifluridine/tipiracil (TAS-102) plus bevacizumab
    Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.

Первичные конечные точки

  • 6-month progression-free survival rate [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • Adverse events [Срок оценки: through study completion, an average of 1 year]
  • Objective response rate [Срок оценки: up to 16 weeks]
  • Progression free survival [Срок оценки: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
  • Overall survival [Срок оценки: From date of enrollment until the date of death from any cause, assessed up to 100 months]

Критерии участия

Критерии включения

  • age over 60 years old, male and female
  • histologically confirmed adenocarcinoma of the colon or rectum
  • patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
  • with or without measurable lesions
  • ECOG 0 to 2, expected survival time over 3 months
  • Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
  • Signed informed consent and willing to follow the study protocol

Критерии исключения

  • symptomatic metastases of central nervous system
  • other primary malignancies
  • uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
  • organ functions that cannot tolerate study treatment
  • bowel obstruction or other conditions affecting oral administration
  • allergic to study medication
  • other conditions that patients are unsuitable for this study assessed by the investigators

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 · 2 центра
  • SanMing First Hospital — Sanming
  • Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT07085169 · TAS-102/2025-No.412

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗