Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
October 27, 2021 updated by: Ming Li, Shanghai 10th People's Hospital
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
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lihong Fan, M.D.
- Phone Number: +8613661599588
- Email: fanlih@aliyun.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 86200072
- Recruiting
- Shanghai 10th People's Hospital
-
Contact:
- Lihong Fan, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: traditional Chinese medicine combined with thermal or cold ablation
|
Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites
|
|
Active Comparator: thermal or cold 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)
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.
|
2 years after ablation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years after ablation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.