- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053802
Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial (MAGIC)
September 13, 2021 updated by: Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
Prospective, multi-center, phase II clinical trial.
The study plans to enroll 146 patients with multiple lung cancers.
After signing the informed consent, they were screened to meet the admission and discharge criteria, and received microwave ablation treatment.
Electromagnetic navigation bronchoscope-guided intrapulmonary microwave ablation or percutaneous microwave ablation was selected according to the patient's wishes and the evaluation of the surgeon.
After the operation, they were randomized and the experimental group accepted PD-1 immune checkpoint inhibitor treatment (microwave ablation combined with Camrelizumab treatment does not exceed 16 cycles, or disease progression/worsening or confirmed imaging disease progression, or withdrawal for any reason), the control group does not After receiving any treatment, the two groups were followed up closely (36 months after the last treatment, including safety follow-up and survival follow-up).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chang Chen, Dr
- Phone Number: 021 65115006
- Email: 2031222@tongji.edu.cn
Study Locations
-
-
Shangh
-
Shanghai, Shangh, China
- Recruiting
- RenJi Hospital
-
Contact:
- Jiachang Chi
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Changhai Hospital
-
Contact:
- Chong Bai, Dr
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Tenth People's Hospital
-
Contact:
- Chuanwu Cao
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai First People's Hospital
-
Contact:
- Zheng Ruan
-
Shanghai, Shanghai, China
- Recruiting
- Ruijin Hospital
-
Contact:
- Wei Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18~79 years old;
- Multiple pulmonary nodules diagnosed by CT, the number of target lesions ≥2 and ≤5 (definition of target lesions: the largest diameter of a single nodule ≥8 mm or the largest diameter of a solid component ≥5mm, and the largest single nodule Diameter ≤30 mm), the target lesions are distributed in at least two lung lobes;
- The target lesions need to be pathologically indicated as lung cancer, and at least one of the target lesions is pathologically diagnosed as lung cancer (at least one target lesion is pathologically diagnosed as lung cancer, and the CT follow-up after anti-inflammatory treatment for the remaining target lesions is clear and stable for no less than 3 months, which is also consistent with the entry Group conditions);
- The patient has no lymph node metastasis, lung metastasis or distant organ metastasis (N0, M0);
- ECOG PS score 0-2;
- Expected survival time ≥ 12 months;
- Sufficient hematology function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥80×109/L, hemoglobin ≥90g/L (no history of blood transfusion within 7 days, no G-CSF and others Correction of hematopoietic stimulating factors);
- Sufficient liver function, defined as all patients with total bilirubin level ≤1.5 times upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN;
- Sufficient renal function, defined as creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
- The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the INR/PT is within the proposed range of anticoagulation drugs Can;
- For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first study drug administration. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required;
- If there is a risk of conception, male and female patients need to use high-efficiency contraception (that is, a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment;
- Subjects voluntarily join the study and sign written informed consent before any trial-related procedures are implemented. They have good compliance and cooperate with follow-up.
Exclusion Criteria:
- Genetic testing is positive for at least one mutation of EGFR, ALK, ROS1 fusion, BRAF V600E mutation, and NTRK fusion;
- Pulmonary nodules with the largest diameter> 30mm in preoperative imaging examination;
- Preoperative imaging examination or mediastinal lymph node puncture indicates patients with positive preoperative lymph nodes;
- Patients with distant metastasis or chest or ascites found in preoperative examination;
- Currently participating in interventional clinical research treatment, or receiving treatment with other research drugs or research devices within 3 months before the first intervention;
- Any systemic anti-tumor treatment before tumor ablation, including interventional chemoembolization, radiotherapy, chemotherapy, targeted therapy, or Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) ), or received major surgery within 3 weeks before the first intervention;
- Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA4, OX-40, CD137);
- There are multiple factors that affect surgery or ablation (such as coagulation dysfunction, immune system disease, etc.);
- Abnormal coagulation function (PT>16 s, APTT>43 s, TT>21 s, Fbg< 2 g/L), bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy;
- Pulmonary hemorrhage ≥ CTCAE grade 2 occurred within 4 weeks before the first intervention; other parts of hemorrhage ≥ CTCAE grade 3 occurred within 4 weeks before treatment;
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis, active hepatitis without treatment;
- People with severe impairment of heart, liver, and kidney functions (heart function grades 3 to 4, ALT and/or AST are more than 3 times the upper limit of normal, and Cr exceeds the upper limit of normal);
- Known mental illness or drug abuse that may affect compliance with test requirements;
- Patients with other malignant tumors or hematological diseases;
- Pregnant, planned pregnancy and breast-feeding female patients (when urine HCG>2500IU/L, it is diagnosed as early pregnancy);
- The investigator believes that it is not suitable for inclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Microwave ablation plus Camrelizumab
Microwave ablation plus Camrelizumab (no more than 16 cycles)
|
Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab
|
Other: Microwave ablation
|
Tumor received treatment of microwave ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1 Year Recurrence-free survival
Time Frame: 1 year
|
1 year
|
3 Year Recurrence-free survival
Time Frame: 3 years
|
3 years
|
Progression-free rate of remaining lesions
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2 Year Recurrence-free survival
Time Frame: 2 years
|
2 years
|
5 Year Recurrence-free survival
Time Frame: 5 years
|
5 years
|
3 year overall survival
Time Frame: 3 years
|
3 years
|
5 year overall survival
Time Frame: 5 years
|
5 years
|
Complication rate
Time Frame: 3 years
|
3 years
|
Quality of life score
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Chang Chen, Dr, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2021
Primary Completion (Anticipated)
September 30, 2025
Study Completion (Anticipated)
September 30, 2027
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
September 13, 2021
First Posted (Actual)
September 23, 2021
Study Record Updates
Last Update Posted (Actual)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L20-349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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