NCT03769129Recruiting
Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC
A Prospective,Single Center, Randomized Control,Phase III Clinical Study for Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Patients With Stage ⅢB-Ⅳ NSCLC Who Failed With First-line Therapy
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 12 Nov 2018
- Start date
- 1 Nov 2018
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT03769129
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Nov 2018 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment.
Other illness
- 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 need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases.
Other
- Patients with two or more kinds of tumors.
- Patients who need long-term use of glucocorticoid.
- Women patients in gestation period or suckling period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| zhang Zhenfeng Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.