Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840408
• Other study ID #: Shanghai
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2019
• Source: Shanghai 10th People's Hospital
• Contact: LiH Fan, M.D.
• Phone: +8613661599588
• Email: fanlih[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1753
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.

• Patients with single nodule.

• Before IIB period according to the eighth edition of the TNM staging period.

• No mediastinal lymph node metastasis.

• No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.

• Eastern Cooperative Oncology Group performance status of 0 to 1

• Sufficient organ functions

Exclusion Criteria:

• Active bacterial or fungous infection.

• Simultaneous or metachronous (within the past 5 years) double cancers.

• Patients with contraindications to radiofrequency ablation and inability to complete treatment;

• Women during pregnancy or breast-feeding.

• Uncontrollable diabetes mellitus.

• Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites

Procedure:
• Surgery
Patients will be treated with surgery

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		From the date of randomization until the date of first documented progression,assessed up to 60 months
Secondary	Overall survival		From the date of randomization until the date of death from any cause,assessed up to 60 months