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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer Stage I
• Intervention / Treatment: Combination product: traditional Chinese medicine and ablation in the primary tumor sites; Procedure: ablation

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihong Fan, M.D.; Phone Number: +8613661599588; Email: fanlih@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 86200072
      • Recruiting
      • Shanghai 10th People's Hospital
      • Contact: Lihong Fan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: traditional Chinese medicine combined with thermal or cold ablation	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
Active Comparator: thermal or cold ablation	Procedure: ablation; Patients will be treated with ablation in the primary tumor sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2021SH10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No