Currently, comprehensive treatments for liver metastasis/pulmonary metastasis that cannot reach NED include systemic chemotherapy, interventional chemotherapy, molecular targeted therapy, immunotherapy, and local treatments (ablation therapy, radiation therapy, etc.) for liver metastases. Combination therapy model of local ablation, systemic chemotherapy, and anti-PD -1 monoclonal antibody hopefully can prolong patient survival. This trial will evaluate the effectiveness and safety of carrelizumab combined with microwave ablation and chemotherapy in the treatment of colorectal cancer liver metastasis/pulmonary metastasis
This is a phase II, single-arm prospective trial of local ablation combined with chemotherapy and camrelizumab for liver metastasis/pulmonary metastasis in colorectal cancer. The enrolled patients received ablation of liver metastases/pulmonary metastasis first, followed by chemotherapy (standard treatment plan for advanced colorectal cancer, determined by the investigator) and camrelizumab treatment (200mg, iv, q3w) one week later. If the patient has multiple metastatic tumors, ablation therapy needs to be performed in multiple times. Sequential chemotherapy and camrelizumab is administered one week after each ablation therapy. Treatment will continue until disease progression, unacceptable toxicity, or voluntary patient withdrawal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
d1,200mg, iv, q3w
the 37 enrolled patients received ablation of liver/lung metastases ,If the patient has multiple metastatic tumors, ablation therapy needs to be performed in multiple times.
standard treatment plan for mCRC, determined by the investigator
12-month progression-free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause,whichever comes first.
Time frame: 1 year
Objective response rate(ORR)
ORR, which is defined as the proportion of subjects who achieve a best response of complete response(CR) or partial response (PR) using the RECIST 1.1 criteria.
Time frame: 3 years
Disease control rate (DCR)
DCR, which is defined as the proportion of subjects who achieve a response of complete response, partial response and stable disease (CR+PR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria.
Time frame: 3 years
progression-free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1
Time frame: 3 years
Overall Survival(OS)
Overall Survival, defined from the date of first treatment to the date of death due to any cause.
Time frame: 3 years
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