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Multiple Primary Lung CancerPhase 2MAGICNCT05053802

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

A Phase 2 study testing Microwave ablation plus Camrelizumab and Microwave ablation in people with Multiple Primary Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Multiple Primary Lung Cancer
What is being tested?
Microwave ablation plus Camrelizumab and Microwave ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
6 sitesChina
Study dates
21 Mar 2021to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chang Chen, Dr contact

65115006 ext. 021

2031222@tongji.edu.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Chong Bai, Dr

    Recruiting

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200433

    Zheng Ruan

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Chang Chen, MD, PhD, +86-021-65115006 ext. 2074, chenthoracic@163.com

    Recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality

    Wei Chen

    Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

    Chuanwu Cao

    Recruiting

  • Renji Hospital

    Shanghai, Shangh

    Jiachang Chi

    Recruiting

Other trials in China

About this study

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).

Being tested
Microwave ablation plus Camrelizumab, Microwave ablation
Keywords
MPLC; Microwave ablation; PD-1 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microwave ablation plus CamrelizumabCombination product

    Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab

  • Microwave ablationDevice

    Tumor received treatment of microwave ablation

Study groups in NCT05053802
Study groupRoleWhat they receive
Microwave ablation plus CamrelizumabExperimentalMicrowave ablation plus Camrelizumab (no more than 16 cycles)
Receives: Combination Product: Microwave ablation plus Camrelizumab
Microwave ablationOtherMicrowave ablation
Receives: Device: Microwave ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 Year Recurrence-free survival

    Measured: 1 year

  2. 3 Year Recurrence-free survival

    Measured: 3 years

  3. Progression-free rate of remaining lesions

    Measured: 5 years

Secondary outcomes (6)

  1. 2 Year Recurrence-free survival

    Measured: 2 years

  2. 5 Year Recurrence-free survival

    Measured: 5 years

  3. 3 year overall survival

    Measured: 3 years

  4. 5 year overall survival

    Measured: 5 years

  5. Complication rate

    Measured: 3 years

  6. Quality of life score

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start21 Mar 2021
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053802
Sponsor's protocol ID
L20-349
Acronym
MAGIC
Status last verified
Sep 2021
First submitted
13 Sep 2021
Last updated
23 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Microwave ablation plus Camrelizumab and Microwave ablation in people with Multiple Primary Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 6 sites in China.

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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chang Chen, Dr (65115006 ext. 021, 2031222@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 Year Recurrence-free survival (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05053802.

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 23 Sep 2021.

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