A Phase 2 interventional study of Camrelizumab and ablation in Colorectal Cancer Metastatic, Liver Metastases and Lung Metastases, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 37 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Drug: Camrelizumab · Procedure: ablation · Drug: chemotherapy
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Harbin Medical University