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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jinfukang + Chemotherapy Group | Experimental |
| |
| Chemotherapy Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jinfukang Koufuye | Drug | 30ml per time, tid, po (d6-21, q21) |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hegen Li | Longhua Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2021 | |
| Unrelease | Feb 26, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2021 | Feb 26, 2021 |
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel |
| Drug |
75mg/m2,ivgtt 30mins, d1 |
|
| Pemetrexed | Drug | 500mg/m2, ivgtt 30mins, d1 |
|
| Cisplatin | Drug | 75mg/m2, ivgtt >2h, d1 |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |