Status:
RECRUITING
The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Lithuanian University of Health Sciences
Collaborating Sponsors:
Research Council of Lithuania
Conditions:
Lung Cancer Stage IV
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Lung cancer remains one of the most commonly diagnosed oncological diseases worldwide and the first in terms of mortality. Although immune checkpoint inhibitors form the backbone of current metastatic...
Eligibility Criteria
Inclusion
- Patients with Eastern Cooperative Oncology Group (ECOG) performance score 0 - 1;
- Patients with histologically confirmed metastatic non-small cell lung cancer and PD-L1 expression on tumor cells was evaluated;
- CT examination shows measurable tumor formations according to the RECIST 1.1 criteria;
- Primary lung tumor or metastasis accessible to flexible bronchoscopy;
- Patients may have received surgery, adjuvant or neoadjuvant chemotherapy prior to the study if it was completed at least 12 months before relapse;
- Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion
- Patients who refused to participate in the clinical trial and did not sign the informed consent form;
- Men and women under the age of 18, pregnant women;
- Patients belonging to a vulnerable social group;
- High risk of general anesthesia, defined as American Society of Anesthesiologists (ASA) class 4 - 6;
- Documented allergy to medications used during general and local anesthesia, systemic cancer treatment;
- Patients previously treated with immune checkpoint inhibitors;
- EGFR mutations or ALK translocations have been identified in patients;
- Patients with previously diagnosed autoimmune diseases, active viral hepatitis, uncontrolled human immunodeficiency virus (HIV) infection or untreated tuberculosis;
- Patients treated with immunosuppressive drugs, systemic corticosteroids, with equivalent doses of prednisolone exceeding 10 mg/day;
- Patients with an increased risk of bleeding during an interventional procedure;
- Acute untreated conditions that would make it impossible to perform an interventional lung procedure.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06000358
Start Date
April 1 2023
End Date
March 31 2026
Last Update
August 21 2023
Active Locations (1)
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1
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT 44307