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Идёт набор NCT05894694

Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer

Фаза IV С лечением Advanced Colorectal Carcinoma

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: first-line scheme+compound kushen injection, palliative care group first-line scheme.
Кому может быть актуально
Состояния в реестре: Advanced Colorectal Carcinoma. 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
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Официальное название

Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform

Обзор

To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

Подробное описание

This study include a multi-center, randomized, parallel controlled clinical trial. The randomized clinical trial will enroll approximately 320 patients. Participants will be randomly divided into experimental (n=160) and control groups (n=160). Patients in the experimental group was treated with first-line scheme + compound kushen injection. Patients in the control group will receive first-line scheme. The primary endpoint is PFS. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Вмешательства

  • Препарат first-line scheme+compound kushen injection
    FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab+compound kushen injection Compound Kushen injection: intravenous infusion, 20ml at a time, diluted with 200ml sodium chloride injection, once a day, each cycle of chemotherapy should reach the cumulative dose of 200ml.
  • Препарат palliative care group first-line scheme
    FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Первичные конечные точки

  • PFS [Срок оценки: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months]
Вторичные конечные точки (3)
  • OS [Срок оценки: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months]
  • 1-year survival rate [Срок оценки: The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment]
  • 1-year PFS rate [Срок оценки: The proportion of patients with tumor progression or death from enrollment.]

Критерии участия

Критерии включения

① Patients with advanced CRC confirmed by pathology or cytology and receiving first-line therapy;② Aged ≥ 18 years old, male or female;③ ECOG score 0-2 points;④ Expected survival ≥ 3 months;⑤ According to RECIST1.1 criteria, at least one detectable lesion;⑥ Voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up.

Критерии исключения

  • Combined with other malignant primary tumors;
  • Immunohistochemistry/polymerase chain reaction/second-generation sequencing results suggest MSI-H/dMMR patients;
  • Patients with recurrence and metastasis within 6 months after radical tumor surgery;
  • Patients who have previously or are undergoing cancer immunotherapy ; Patients undergoing radiation therapy;
  • Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ Psychiatric patients; ⑦ Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ Patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ Patients who are known to be allergic to or intolerant of study drugs.

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
  • Guang 'anmen Hospital, China Academy of Chinese Medical Sciences — Пекин

Публикации

  • Wu J, Ge Y, Zhu G, Gao R, Zhu X, Zhang Y, Li J. Combination of Compound Kushen injection with first-line treatment versus first-line treatment alone for advanced colorectal cancer: a study protocol for a multicenter, openlabel, randomized controlled trial. BMC Complement Med Ther. 2024 Dec 31;24(1):429. doi: 10.1186/s12906-024-04725-6. PMID 39741233

Идентификаторы

NCT: NCT05894694 · 2023-063-KY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗