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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 | Clinical Trials | Clareo Health

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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

NCT05053802•Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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. 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).

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria