RecruitingPhase 2NCT05053802

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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

146 participants

Start Date

Mar 21, 2021

Study Type

INTERVENTIONAL

Conditions

Multiple Primary Lung Cancer

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining microwave ablation (a minimally invasive procedure that uses heat to destroy tumor tissue) with immune checkpoint inhibitor drugs to treat people who have multiple lung cancers (separate tumors in different parts of the lungs). **You may be eligible if...** - You are 18–79 years old with 2–5 lung nodules seen on CT scan - At least one of your nodules has been confirmed as lung cancer - Your individual tumors are between 8 mm and 30 mm in size, spread across at least two lung lobes - You are in good overall health and can tolerate the procedures **You may NOT be eligible if...** - You have active autoimmune disease or are on immunosuppressive therapy - You have had prior immunotherapy - You have severe lung, heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMicrowave ablation plus Camrelizumab

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

DEVICEMicrowave ablation

Tumor received treatment of microwave ablation