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.
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;
Liver function Child-Pugh class C;
Expected survival < 3 months;
Major organ insufficiency or failure;
Active infection;
Single group
Multi-mode tumor treatment system
DeviceAll 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.
Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
DrugSystemic 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.）
Progression Free Survival (PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the criteria for documented progression of disease (or until death due to any cause) are met, whichever comes first according to RECIST 1.1.
Local Progression Free Survival (LPFS)
Local progression-free survival (LPFS) is defined as the time from the start of treatment until documented local progression of the lesion(s) under assessment, or until death from any cause, whichever comes first according to RECIST 1.1.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment according to RECIST 1.1.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the start of treatment until death from any cause.
Rate of adverse events
The rate of adverse events will be calculated as the number of participants experiencing any adverse event divided by the total number of participants enrolled in the study.
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