Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC
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.
| Condition(s) | Non Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Pathologically diagnosed IIIB or IV non-small cell lung cancer. 2. Previously accepted first-line standard treatment failure or recurrence 3. At least one measurable lesion. 4. The patient has not received any other anti-cancer treatment within four weeks. 5. Any gender, age ≥18 years 6. ECOG PS : 0-2 points 7. Expected survival ≥ 6 months 8. The level of organ function meets the following criteria. (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). 9\. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contra |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2018-11-01 |
| NCT ID | NCT03769129 |
| Official listing | https://clinicaltrials.gov/study/NCT03769129 |