Back to resultsA Trial of Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis
Primary Purpose
Colorectal Cancer Metastatic, Liver Metastases, Lung Metastases
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camrelizumab
ablation
chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic
Eligibility Criteria
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:
- Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures;
- Suffer from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled;
- Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
- Subjects with active, known or suspected autoimmune diseases, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected
- Patients with active hepatitis B or C, chronic infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 500 IU/mL are allowed to participate in the study, but need to continue during the study period or start a full-course standardized antiviral treatment;
- Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery;
- Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period;
- Those who are allergic to test drugs;
- Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Camrelizumab;
- Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
- The researcher believes that it is inappropriate to participate in this trial.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab+ablation +chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
progression-free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1
Overall Survival(OS)
Overall Survival, defined from the date of first treatment to the date of death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04888806
Brief Title
A Trial of Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis
Official Title
Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis -a Single-arm Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic, Liver Metastases, Lung Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab+ablation +chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
d1，200mg, iv, q3w
Intervention Type
Procedure
Intervention Name(s)
ablation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Description
standard treatment plan for mCRC, determined by the investigator
Primary Outcome Measure Information:
Title
12-month progression-free survival (PFS)
Description
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
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
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
Title
Disease control rate (DCR)
Description
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
Title
progression-free survival (PFS)
Description
The date of first treatment until the date of progression using the RECIST 1.1
Time Frame
3 years
Title
Overall Survival(OS)
Description
Overall Survival, defined from the date of first treatment to the date of death due to any cause.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures;
Suffer from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled;
Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
Subjects with active, known or suspected autoimmune diseases, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected
Patients with active hepatitis B or C, chronic infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 500 IU/mL are allowed to participate in the study, but need to continue during the study period or start a full-course standardized antiviral treatment;
Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery;
Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period;
Those who are allergic to test drugs;
Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Camrelizumab;
Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
The researcher believes that it is inappropriate to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqiao Zhang, Ph D
Phone
13845120210
Email
yanqiaozhang@126.com
12. IPD Sharing Statement
Learn more about this trial
A Trial of Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis
We'll reach out to this number within 24 hrs