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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2023

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: traditional Chinese medicine combined with thermal or cold ablation
  • Active Comparator: thermal or cold ablation

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate (ORR)
    • Time Frame: 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 Measures

  • DFS
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai 10th People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ming Li, senior doctor – Shanghai 10th People’s Hospital
  • Overall Contact(s)
    • Lihong Fan, M.D., +8613661599588, fanlih@aliyun.com

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