ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Официальное название

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Вмешательства

• Процедура Colorectal cancer resection combined with liver metastasis resection.
  The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.
• 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.

Первичные конечные точки

• 3-year progression-free survival [Срок оценки: 3 years after operation.]
• 5-year progression-free survival [Срок оценки: 5 years after operation.]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
• Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
• Patients with negative ctDNA after surgery;
• ASA grade <IV and/or ECOG performance status score ≤ 2;
• Have sufficient understanding of the study and voluntarily sign an informed consent form.

Критерии исключения

• Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
• Patients with a history of other malignancies;
• Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
• Patients who are allergic to any component in the study;
• Patients who have received other tumor-related investigational drug therapy;
• Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
• Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
• Patients with a history of severe mental illness;
• Pregnant or lactating women;
• Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

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: NCT05815082 · 1010(CG)2022-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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