Status:
UNKNOWN
Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
NSCLC and Theropy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Based on the recommendations of the guidelines, as well as the previous animal studies and clinical studies of our team, we designed and carried out prospective, randomized controlled, double-blind cl...
Detailed Description
OBJECTIVES: To verify the efficacy of radiofrequency ablation combined with melatonin in the treatment of stage IA non-small cell lung cancer, and explore new directions for the prevention and treatm...
Eligibility Criteria
Inclusion
- (1) Patients can understand and voluntarily join this study, sign an informed consent form, and have good compliance.
- (2) Patients with peripheral early lung cancer who cannot tolerate surgery with poor cardiopulmonary function; (3) Patients with peripheral early-stage lung cancer who cannot tolerate surgery; (4) Patients with peripheral early lung cancer who are unwilling to undergo surgery; (5) The tumor is more than 1.0 cm away from large blood vessels or larger bronchi.
- (6) Age ≥18 years old and ≤85 years old; (7) ECOG PS score: 0-2 points; (8) Good coagulation function, platelet count ≥100×10\^9/L, INR and PT≤1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of anticoagulation drugs; (9) Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before study entry Negative, and must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
Exclusion
- (1) Those with severe comorbidities, infection period, and immunocompromised persons; (2) Patients who are judged to seriously affect survival or cannot tolerate thoracoscopic surgery in pre-assessment; (3) Patients who have contraindications to radiofrequency ablation and cannot complete the treatment; (4) Merge other organ/system tumors. (5) At present, patients with long-term oral hormones and autoimmune diseases (6) Various bleeding diseases, acute infectious diseases, fever, women during pregnancy, (7) Recovery period after heart surgery or stent implantation. (8) Those who are difficult to cooperate to complete the baseline test; those who cannot take drugs regularly;
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04530097
Start Date
January 1 2021
End Date
September 30 2022
Last Update
August 28 2020
Active Locations (1)
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1
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China, +86200072