Back to resultsTraditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer Stage I
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional Chinese medicine and ablation in the primary tumor sites
ablation
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Stage I
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 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
Sites / Locations
- Shanghai 10th People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
traditional Chinese medicine combined with thermal or cold ablation
thermal or cold ablation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05097417
First Posted
June 29, 2021
Last Updated
October 27, 2021
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05097417
Brief Title
Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
Official Title
A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage I
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional Chinese medicine combined with thermal or cold ablation
Arm Type
Experimental
Arm Title
thermal or cold ablation
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
traditional Chinese medicine and ablation in the primary tumor sites
Intervention Description
Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites
Intervention Type
Procedure
Intervention Name(s)
ablation
Intervention Description
Patients will be treated with ablation in the primary tumor sites
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
2 years after ablation
Secondary Outcome Measure Information:
Title
DFS
Description
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.
Time Frame
2 years after ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lihong Fan, M.D.
Phone
+8613661599588
Email
fanlih@aliyun.com
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
86200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Fan, M.D.
12. IPD Sharing Statement
Learn more about this trial
Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
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