Status:
RECRUITING
Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- Pathologically diagnosed IIIB or IV non-small cell lung cancer.
- Previously accepted first-line standard treatment failure or recurrence
- At least one measurable lesion.
- The patient has not received any other anti-cancer treatment within four weeks.
- Any gender, age ≥18 years
- ECOG PS : 0-2 points
- Expected survival ≥ 6 months
- 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
- Patients with two or more kinds of tumors.
- Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment.
- Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection.
- Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously.
- Patients with severe heart and lung dysfunction.
- Patients with severe chronic diseases of kidney, liver and other important organs.
- 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.
- Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment.
- Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases.
- Patients who need long-term use of glucocorticoid.
- Women patients in gestation period or suckling period.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03769129
Start Date
November 1 2018
End Date
November 1 2029
Last Update
June 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
zhang Zhenfeng
Guangzhou, Guangdong, China