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

Non-small Cell Lung Cancer Stage I Clinical Trial

Official title:

A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097417
• Other study ID #: 2021SH10
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2021
• Source: Shanghai 10th People's Hospital
• Contact: Lihong Fan, M.D.
• Phone: +8613661599588
• Email: fanlih[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer Stage I

Intervention

Combination Product:
• 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

Procedure:
• ablation
Patients will be treated with ablation in the primary tumor sites

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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.	2 years after ablation
Secondary	DFS	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.	2 years after ablation