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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+ablation +chemotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | d1,200mg, iv, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Two types of imaging or histology/cytology confirmed colorectal cancer patients with liver metastasis/lung metastasis ;
Must have CT or MRI examination for the past 3 months;
In addition to ablation lesions, there are measurable metastatic lesions (spiral CT scan ≥10mm, meet mRECIST 1.1 standard);
Expected survival time> 3 months;
Patients who have received at least one prior systemic treatment;
The damage caused by the subject receiving other treatments has been restored;
Known KRAS, NRAS, BRAF and HER2 gene status;
Age: 18 to 70 years old, no gender limit;
ECOG PS: 0-2 points;
The functions of vital organs meet the following requirements:
.Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin
≥9g/dL;
. Bilirubin ≤1.5 times ULN (can be included in patients drained by retrograde technique); ALT and AST
≤5 times ULN
. Creatinine <120μmol/ L, or MDRD creatinine clearance rate> 60 mL/min
Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and for 6 months after the last treatment dose is administered
Signature of patient information and informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqiao Zhang, Ph D | Contact | 13845120210 | yanqiaozhang@126.com |
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| ablation |
| Procedure |
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. |
|
| chemotherapy | Drug | standard treatment plan for mCRC, determined by the investigator |
|
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.
| 3 years |
| progression-free survival (PFS) | The date of first treatment until the date of progression using the RECIST 1.1 | 3 years |
| Overall Survival(OS) | Overall Survival, defined from the date of first treatment to the date of death due to any cause. | 3 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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