NCT03769129 Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC
| NCT ID | NCT03769129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-11-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-11-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 contraceptive measures until 6months after therapy. 10\. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up. Exclusion Criteria: 1. Patients with two or more kinds of tumors. 2. Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment. 3. Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection. 4. Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously. 5. Patients with severe heart and lung dysfunction. 6. Patients with severe chronic diseases of kidney, liver and other important organs. 7. Patients with any other serious illness that the investigators consider it will may affect the patient's treatments, follow-up or assessment, including any uncontrolled clinically significant neurological or psychiatric disorders, immunoregulatory diseases, metabolic diseases, infectious diseases and so on. 8. Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment. 9. Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases. 10. Patients who need long-term use of glucocorticoid. 11. Women patients in gestation period or suckling period.
Contact & Investigator
zhang zhenfeng, MD,PHD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT03769129 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03769129 currently recruiting?
Yes, NCT03769129 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT03769129 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03769129 clinical trial?
NCT03769129 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is zhang zhenfeng, MD,PHD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 100 participants.
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