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

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Sep 13, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with multiple primary lung cancers, which means having more than one cancerous spot in the lungs. The study will enroll 146 participants who are between the ages of 18 and 79 and have been diagnosed with at least two lung nodules that are cancerous. After signing up, participants will receive a treatment called microwave ablation, which uses heat to destroy cancer cells. Some participants will also receive an additional treatment called Camrelizumab, which helps boost the body’s immune response against cancer, while others will not receive this extra treatment. The goal is to see how well this combination works and to monitor for any side effects over a follow-up period of three years.

To be eligible for the trial, participants need to have multiple lung nodules that are confirmed to be cancerous, with no spread to lymph nodes or other parts of the body. They should also be in good overall health and able to meet specific blood and organ function requirements. Throughout the trial, all participants will be regularly checked to see how they respond to the treatment and to ensure their safety. If you're considering joining this study, it's important to discuss it with your doctor to understand how it might fit your treatment plan.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18～79 years old;
• • 2. 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;
• • 3. 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);
• • 4. The patient has no lymph node metastasis, lung metastasis or distant organ metastasis (N0, M0);
• • 5. ECOG PS score 0-2;
• • 6. Expected survival time ≥ 12 months;
• • 7. 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);
• • 8. 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;
• • 9. Sufficient renal function, defined as creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
• • 10. 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;
• • 11. 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;
• • 12. 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;
• • 13. 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:
• • 1. Genetic testing is positive for at least one mutation of EGFR, ALK, ROS1 fusion, BRAF V600E mutation, and NTRK fusion;
• • 2. Pulmonary nodules with the largest diameter\> 30mm in preoperative imaging examination;
• • 3. Preoperative imaging examination or mediastinal lymph node puncture indicates patients with positive preoperative lymph nodes;
• • 4. Patients with distant metastasis or chest or ascites found in preoperative examination;
• • 5. Currently participating in interventional clinical research treatment, or receiving treatment with other research drugs or research devices within 3 months before the first intervention;
• • 6. 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;
• • 7. 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);
• • 8. There are multiple factors that affect surgery or ablation (such as coagulation dysfunction, immune system disease, etc.);
• • 9. 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;
• • 10. 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;
• • 11. 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;
• • 12. 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);
• • 13. Known mental illness or drug abuse that may affect compliance with test requirements;
• • 14. Patients with other malignant tumors or hematological diseases;
• • 15. Pregnant, planned pregnancy and breast-feeding female patients (when urine HCG\>2500IU/L, it is diagnosed as early pregnancy);
• • 16. The investigator believes that it is not suitable for inclusion.