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

NCT ID: NCT03840408

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1753 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mitochondrial therapy with radiofrequency ablation

Group Type EXPERIMENTAL

Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation

Intervention Type OTHER

Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites

Surgery

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Patients will be treated with surgery

Interventions

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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

Intervention Type OTHER

Surgery

Patients will be treated with surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Li

Associate senior doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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LiH Fan, M.D.

Role: CONTACT

+8613661599588

Ming Li, M.D.

Role: CONTACT

+8613524348108

Facility Contacts

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Ming Li, M.D.

Role: primary

+8613524348108

Other Identifiers

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Shanghai

Identifier Type: -

Identifier Source: org_study_id

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