A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

Официальное название

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)

Обзор

The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.

Подробное описание

This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.

This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.

Вмешательства

• Устройство Multi-mode tumor treatment system
  All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. Complete ablation of intrahepatic lesions is achieved to realize an intrahepatic no-evidence-of-disease (NED) state. For lesions that could not be ablated in a single session, two treatments are performed to achieve NED within the liver.
• Препарат Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
  Systemic therapy including PD-1 inhibitor starts on the 7th day after ablation (sintilimab 200 mg IV D1 + mFOLFOX6 or FOLFIRI + bevacizumab or cetuximab (determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.）

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: max 24 months]

Вторичные конечные точки (5)

• Local Progression Free Survival (LPFS) [Срок оценки: max 24 months]
• Objective Response Rate (ORR) [Срок оценки: max 24 months]
• Overall Survival (OS) [Срок оценки: max 24 months]
• Rate of adverse events [Срок оценки: max 24 months]
• Immune indicator analysis [Срок оценки: max 24 months]

Критерии участия

Критерии включения

• Age 18-75 years, gender not specified;
• Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
• In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
• Failure of first-line treatment, with disease progression or new liver metastases;
• No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
• For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
• Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L;
• ECOG PS ≤ 2;
• Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Критерии исключения

• Liver function Child-Pugh class C;
• Expected survival < 3 months;
• Major organ insufficiency or failure;
• Active infection;
• Irreversible coagulation disorders;
• Refractory massive ascites, pleural effusion or cachexia;
• Unable to cooperate with treatment;
• Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.

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 · 1 центр

• Shanghai Sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT06590259 · 20231124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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