Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

NCT ID: NCT05097417

Last Updated: 2021-10-28

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-11-01

Brief Summary

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Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold 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 evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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traditional Chinese medicine combined with thermal or cold ablation

Group Type EXPERIMENTAL

traditional Chinese medicine and ablation in the primary tumor sites

Intervention Type COMBINATION_PRODUCT

Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites

thermal or cold ablation

Group Type ACTIVE_COMPARATOR

ablation

Intervention Type PROCEDURE

Patients will be treated with ablation in the primary tumor sites

Interventions

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traditional Chinese medicine and ablation in the primary tumor sites

Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites

Intervention Type COMBINATION_PRODUCT

ablation

Patients will be treated with ablation in the primary tumor sites

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 lung nodule.
* Maximum diameter of lung nodule ≥8mm.
* The pathology of lung nodules biopsy was non-small cell lung cancer.
* I period according to the eighth edition of the TNM staging period.
* No mediastinal lymph node metastasis.
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
* Sufficient organ functions.

Exclusion Criteria

* Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
* Women during pregnancy or breast-feeding.
* Patients with severe heart, lung, kidney disease or other systemic diseases
* Patients with severe hemorrhagic diseases.
* Patients with a history of drug abuse or mental illness.
* Other conditions that the investigator has determined are not suitable for participation in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

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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Lihong Fan, M.D.

Role: CONTACT

Phone: +8613661599588

Email: [email protected]

Facility Contacts

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Lihong Fan, M.D.

Role: primary

Other Identifiers

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2021SH10

Identifier Type: -

Identifier Source: org_study_id