the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs (CTC-TCM-FZ)
Primary Purpose
Non-small Cell Lung Cancer(NSCLC)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JinFuKang
Cisplatin
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer(NSCLC) focused on measuring Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)
Eligibility Criteria
Inclusion Criteria:
- Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
- Patients receiving chemotherapy for the first time in 6 weeks after surgery;
- Age from 18 Years to 70 Years;
- The liver and renal function were normal,and no other disease.
- Patients compliance is good ang can understand the situation of this study and signed informed consent
Exclusion Criteria:
- Patients without clear pathological diagnosis;
- The expected survival period is morn than 6 months;
- Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
- Patients with pregnancy or lactation;
- Persons with a history of less control.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Arm Label
Cisplatin
Pemetrexed
Jinfukang
Arm Description
Cisplatin
Pemetrexed
Jinfukang
Outcomes
Primary Outcome Measures
Progression-Free Survival
It is decided by a doctor via the clinical examinations
Secondary Outcome Measures
Circulating Tumor Cell
It is decided by a doctor via the clinical examinations
Overall survival
It is decided by a doctor via the clinical examinations
Full Information
NCT ID
NCT02603003
First Posted
October 21, 2015
Last Updated
September 18, 2019
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02603003
Brief Title
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
Acronym
CTC-TCM-FZ
Official Title
A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
Detailed Description
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of 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(NSCLC)
Keywords
Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cisplatin
Arm Type
Placebo Comparator
Arm Description
Cisplatin
Arm Title
Pemetrexed
Arm Type
Placebo Comparator
Arm Description
Pemetrexed
Arm Title
Jinfukang
Arm Type
Experimental
Arm Description
Jinfukang
Intervention Type
Drug
Intervention Name(s)
JinFuKang
Other Intervention Name(s)
Jin Fukang oral liquid
Intervention Description
po.tid.30ml
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Navelbine
Intervention Description
According to the individual patient's condition
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Pemetrexeddisodium for Injection
Intervention Description
According to the individual patient's condition
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
It is decided by a doctor via the clinical examinations
Time Frame
The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
Secondary Outcome Measure Information:
Title
Circulating Tumor Cell
Description
It is decided by a doctor via the clinical examinations
Time Frame
24months
Title
Overall survival
Description
It is decided by a doctor via the clinical examinations
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
Patients receiving chemotherapy for the first time in 6 weeks after surgery;
Age from 18 Years to 70 Years;
The liver and renal function were normal,and no other disease.
Patients compliance is good ang can understand the situation of this study and signed informed consent
Exclusion Criteria:
Patients without clear pathological diagnosis;
The expected survival period is morn than 6 months;
Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
Patients with pregnancy or lactation;
Persons with a history of less control.
12. IPD Sharing Statement
Learn more about this trial
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
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