NSCLC Clinical Trial
Official title:
The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
Verified date | September 2017 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB 2. Accept chemotherapy for the first time 6 weeks after operation 3. Age of 18-75 years old 4. Eastern Cooperative Oncology Group-PS=2 5. N>1.5×109/L?PLT> 100 × 109/L?Hb>100g/dL?Liver and kidney function is normal or elevated = 1.5 times 6. Voluntary participation in the prospective study with signed informed consent Exclusion Criteria: 1. No pathology-confirmed diagnosis patients 2. Patients with overall survival time<6 months 3. Patients with Serious diseases like heart?liver?kidney and hematopoietic system at the same time 4. Pregnant or breast feeding patients 5. Patients with uncontrollable mentally disease 6. Patients with diabetes |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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lihegen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival Rate | From the very beginning of the randomization to the end point when disease relapse or death because of any reason | 2 years |
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