theFuzheng Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study on theFuzhengTherapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation

Conditions
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Non-small Cell Lung Cancer(NSCLC)

Intervention / Treatment
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* Drug: JinFuKang
* Drug: Cisplatin
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cisplatin<br>Cisplatin | Drug: Cisplatin<br>* According to the individual patient's condition<br>* Other names: Navelbine;|
| Placebo Comparator: Pemetrexed<br>Pemetrexed | Drug: Pemetrexed<br>* According to the individual patient's condition<br>* Other names: Pemetrexeddisodium for Injection;|
| Experimental: Jinfukang<br>Jinfukang | Drug: JinFuKang<br>* po.tid.30ml<br>* Other names: Jin Fukang oral liquid;Drug: Cisplatin<br>* According to the individual patient's condition<br>* Other names: Navelbine;Drug: Pemetrexed<br>* According to the individual patient's condition<br>* Other names: Pemetrexeddisodium for Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | It is decided by a doctor via the clinical examinations | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating Tumor Cell | It is decided by a doctor via the clinical examinations | 24months | 
| Overall survival | It is decided by a doctor via the clinical examinations | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)