An interventional study of Pembrolizumab and microwave ablation in Non Small Cell Lung Cancer, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
This is a prospective, randomized, single clinical study designed to evaluate its safety and efficacy by using Microwave Ablation combine with Pembrolizumab in patients with Stage ⅢB-Ⅳ Non-small Cell Lung.Cancer (NSCLC) who failed with first-line therapy.
Lung cancer is one of the most common malignant tumors in the world and has become the No. 1 cause of death from malignant tumors in China. Non-small cell lung cancer (NSCLC) includes squamous cell carcinomas, adenocarcinomas, and large cell carcinomas and accounts for about 80-85% of all lung cancers. NSCLC cancer cells divide slowly in a diffusive manner and metastasize at a relatively late stage compared to small cell carcinomas. A majority of patients with NSCLC are already in advanced stages and have a low 5-year survival rate.
Treatments for advanced NSCLC include chemotherapy ,targeted therapies and immunotherapy. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. A large number of studies have shown that local minimally invasive ablation therapy within a certain temperature range can stimulate the body to produce an immune response to varying degrees. The study found that for a variety of malignant tumor models, thermal ablation local treatment of in situ tumors, while the disappearance of other metastatic lesions, and treated mice are resistant to secondary vaccination of the same tumor, proving that thermal ablation therapy stimulates long-lasting Anti-tumor immunity. Pembrolizumab are representative drugs for immunosuppressive agents, and its indications have been approved in various types of tumors, including advanced melanoma, advanced squamous non-small cell lung cancer, advanced renal cell carcinoma, and classical Hodgkin's lymphoma and late recurrent head and neck squamous cell carcinoma patients. Whether the combination of the two can cause a stronger anti-tumor immune response in the body. However, the flexibility, safety and efficacy of using Microwave Ablation combine with Pembrolizumab in NSCLC patients are still unclear.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
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(1) subject to the standard blood test: ANC ≥ 1.5×109 / L, PLT ≥ 50×109 / L, Hb ≥ 90g/L.
(2) biochemical tests must meet the following criteria: TBIL\<1.5×ULN, ALT, AST \<2.5×ULN ( if liver metastasis ALT, AST can be \<5×ULN), BUN, and Cr ≤ 1×ULN).
Exclusion Criteria:
Firstly, microwave ablation performed at our department by interventional radiologist, then Pembrolizumab will be administered at a dose of 2 mg/kg every three weeks.
Drug: Pembrolizumab · Procedure: microwave ablation
Firstly, pembrolizumab was administered intravenously at a dose of 2 mg/kg. Then microwave ablation will be performed if there is no immune-related adverse reactions. Pembrolizumab will also be continuously administered every three weeks until the imaging evaluation of the disease progress.
Drug: Pembrolizumab · Procedure: microwave ablation
Pembrolizumab
Also known as: Keytruda
microwave ablation
Overall survival
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events（Safety）
All the local reactions, systemic reactions, all the adverse events and serious adverse events obtained during the study of all the patients included in the first stage and the second stage of this study
Time frame: 2 years
Progression-Free Survival
From enrollment to progression of disease.
Time frame: 2 years
Plan to share: No — Don not plan
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Carcinoma, Non-Small-Cell Lung→
Second Affiliated Hospital of Guangzhou Medical University