Colorectal Cancer MetastaticPhase 2NCT04888806
A Trial of Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis
A Phase 2 study testing Camrelizumab, ablation and chemotherapy in people with Colorectal Cancer Metastatic and Liver Metastases, run by Harbin Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer Metastatic, Liver Metastases, Lung Metastases
- What is being tested?
- Camrelizumab, ablation and chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis -a Single-arm Prospective Study
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
Read the 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.
- Being tested
- Camrelizumab, ablation, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
d1，200mg, iv, q3w
ablationProcedure or surgery
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.
chemotherapyDrug
standard treatment plan for mCRC, determined by the investigator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Camrelizumab; Procedure: ablation; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 3 years
progression-free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1
Measured: 3 years
Overall Survival(OS)
Overall Survival, defined from the date of first treatment to the date of death due to any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqiao Zhang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888806
- Sponsor's protocol ID
- SHR-1210-HLJ-019
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis -a Single-arm Prospective Study
- ClinicalTrials.gov ID
- NCT04888806
- Acronym / sponsor ID
- SHR-1210-HLJ-019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+ablation +chemotherapy | Experimental | Drug: Camrelizumab, Procedure: ablation, Drug: chemotherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumabd1，200mg, iv, q3w | Drug | Camrelizumab+ablation +chemotherapy |
| ablationthe 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. | Procedure or surgery | Camrelizumab+ablation +chemotherapy |
| chemotherapystandard treatment plan for mCRC, determined by the investigator | Drug | Camrelizumab+ablation +chemotherapy |
Primary outcome
12-month progression-free survival (PFS)
Time frame: 1 year
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.
4 secondary outcomes
Objective response rate(ORR)
Time frame: 3 years
Disease control rate (DCR)
Time frame: 3 years
progression-free survival (PFS)
Time frame: 3 years
Overall Survival(OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, ablation and chemotherapy in people with Colorectal Cancer Metastatic and Liver Metastases, run by Harbin Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqiao Zhang, Ph D (13845120210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month progression-free survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.