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

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer Stage I
• Interventions: Procedure: ablation; Combination Product: traditional Chinese medicine and ablation in the primary tumor sites

• Registration Number: NCT05097417
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-10-28
• Last Update Posted: 2021-10-28
• Study Start: 2021-11-01
• Primary Completion: 2023-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thermal or cold ablation	ablation	-
traditional Chinese medicine combined with thermal or cold ablation	traditional Chinese medicine and ablation in the primary tumor sites	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 years after ablation	Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.

Secondary Outcome Measures

Name	Time	Method
DFS	2 years after ablation	The time interval from the first medication to the observation of recurrence or metastasis, or death from any cause (calculated based on the previous event). Patients who have not relapsed, metastasized or died at the time of the data cutoff, and those who were lost to follow-up in the study will be counted on the date of their last tumor evaluation.

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China