Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Jinfukang Koufuye
* Drug: Docetaxel
* Drug: Pemetrexed
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB Accept chemotherapy for the first time 6 weeks after operation Age of 18-75 years old Eastern Cooperative Oncology Group-PS≤2 N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times Voluntary participation in the prospective study with signed informed consent Exclusion Criteria: No pathology-confirmed diagnosis patients Patients with overall survival time<6 months Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time Pregnant or breast feeding patients Patients with uncontrollable mentally disease Patients with diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jinfukang + Chemotherapy Group<br> | Drug: Jinfukang Koufuye<br>* 30ml per time, tid, po (d6-21, q21)<br>Drug: Docetaxel<br>* 75mg/m2,ivgtt 30mins, d1<br>Drug: Pemetrexed<br>* 500mg/m2, ivgtt 30mins, d1<br>Drug: Cisplatin<br>* 75mg/m2, ivgtt >2h, d1<br>|
| Placebo Comparator: Chemotherapy Group<br> | Drug: Docetaxel<br>* 75mg/m2,ivgtt 30mins, d1<br>Drug: Pemetrexed<br>* 500mg/m2, ivgtt 30mins, d1<br>Drug: Cisplatin<br>* 75mg/m2, ivgtt >2h, d1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |