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

T

Tongji University

Status

Unknown

Conditions

Non Small Cell Lung Cancer

Treatments

Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Procedure: Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03840408
Shanghai

Details and patient eligibility

About

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.

Enrollment

1,753 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,753 participants in 2 patient groups

Mitochondrial therapy with radiofrequency ablation
Experimental group
Treatment:
Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Surgery
Active Comparator group
Treatment:
Procedure: Surgery

Trial contacts and locations

1

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Central trial contact

Ming Li, M.D.; LiH Fan, M.D.

Data sourced from clinicaltrials.gov

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