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

Shanghai University of Traditional Chinese Medicine218 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

218

Conditions

Non-small Cell Lung Cancer(NSCLC)

Interventions

JinFuKangDRUG

po.tid.30ml

CisplatinDRUG

According to the individual patient's condition

PemetrexedDRUG

According to the individual patient's condition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Complete resection was accepted in IIa \~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients; 2. Patients receiving chemotherapy for the first time in 6 weeks after surgery; 3. Age from 18 Years to 70 Years; 4. The liver and renal function were normal,and no other disease. 5. Patients compliance is good ang can understand the situation of this study and signed informed consent Exclusion Criteria: 1. Patients without clear pathological diagnosis; 2. The expected survival period is morn than 6 months; 3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system; 4. Patients with pregnancy or lactation; 5. Persons with a history of less control.

Outcomes

Primary Outcomes

Progression-Free Survival

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 Outcomes

Circulating Tumor Cell

It is decided by a doctor via the clinical examinations

Time frame: 24months

Overall survival

It is decided by a doctor via the clinical examinations

Time frame: Two years

Data from ClinicalTrials.gov

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