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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Chang Chen, Dr · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-21
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053802 on ClinicalTrials.gov