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
Study ID
NCT05053802
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple Primary Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Microwave ablation plus Camrelizumab — COMBINATION_PRODUCT
    Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab
  • Microwave ablation — DEVICE
    Tumor received treatment of microwave ablation

Study Details

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).

Key Dates

Start date
Mar 21, 2021
Status verified
Sep 2021
Primary completion
Sep 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Microwave ablation plus Camrelizumab
    Microwave ablation plus Camrelizumab (no more than 16 cycles)
  • Other: Microwave ablation
    Microwave ablation

Primary Outcome Measure

1 Year Recurrence-free survival [ Time Frame: 1 year ]

Central Contacts