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

Tongji University

Status: Enrolling

Conditions: Non-small Cell Lung Cancer Stage I

Treatments: Combination Product: traditional Chinese medicine and ablation in the primary tumor sites; Procedure: ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05097417

2021SH10

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

traditional Chinese medicine combined with thermal or cold ablation

Experimental group

Treatment:

Combination Product: traditional Chinese medicine and ablation in the primary tumor sites

thermal or cold ablation

Active Comparator group

Treatment:

Procedure: ablation