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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Primary Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Microwave ablation plus Camrelizumab	Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab
DEVICE	Microwave ablation	Tumor received treatment of microwave ablation

Timeline

• Start date: 2021-03-21
• Primary completion: 2025-09-30
• Completion: 2027-09-30
• First posted: 2021-09-23
• Last updated: 2021-09-23

Locations

6 sites across 1 country: China