Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Официальное название

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

Обзор

The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

Вмешательства

• Процедура Colorectal resection surgery.
  Colorectal cancer radical resection combined with liver metastasis resection or ablation.
• Препарат FOLFOX chemotherapy regimen
  Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
• Препарат Capecitabine
  Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.

Первичные конечные точки

• 3-years Progression Free Survival [Срок оценки: 3 years after operation.]
• 5-years Progression Free Survival [Срок оценки: 5 years after operation.]

Вторичные конечные точки (3)

• 3-years overall survival [Срок оценки: 3 years after operation.]
• 5-years overall survival [Срок оценки: 5 years after operation.]
• Complication [Срок оценки: 5 years.]

Критерии участия

Критерии включения

• Both males and females, aged 18-75 years;
• Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
• Postoperative ctDNA-positive patients;
• ASA grade < IV and/or ECOG performance status score ≤ 2;
• Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Критерии исключения

• Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
• Patients with a history of other malignant tumors.
• Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
• Patients who are allergic to any component of the study.
• Patients who have received other tumor-related investigational drug treatments.
• Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
• Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.
• Patients with a history of severe mental illness.
• Pregnant or lactating women.
• Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

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

• The Sixth Affiliate Hospital of Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT05797077 · 1010(PY)2022-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗