A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer Stage I
- Sponsor
- Shanghai 10th People's Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ming Li
senior doctor
Shanghai 10th People's Hospital
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
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 Outcomes
- DFS(2 years after ablation)