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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
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The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer.
The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged.
The primary end point is: Objective response rate;
The secondary end points are:
The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate,prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy | Active Comparator | Eligible subjects will be treated with platinum-doublet 2 cycles chemotherapy:pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin. Each cycle was 21-days. Dosage:pemetrexed i.v.500mg/m2 d1 ; docetaxel i.v.75mg/m2 d1 ; gemcitabine i.v.1250 mg/m2 d1,d8 ; paclitaxel i.v.175mg/m2 d1 ; vinorelbine i.v.25mg/m2 d1,d8; carboplatin i.v.area under curve (AUC) 5 d1 ;cis-platinum i.v.75mg/m2 d1(or divided into 3days);nedaplatin i.v.80mg/m2 d1. |
|
| TCM combined chemotherapy | Experimental | TCM:JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JinFuKang | Drug | treated with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer. | From date of randomization until the date of first documented progression or date of death from any cause,up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | up to 2 months | |
| Time-to-Progression | up to 2 months | |
| Number of participants with treatment-related quality of life as assessed by FACT-L4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HEGEN LI | Shanghai University of Traditional Chinese Medicine | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 2, 2019 | |
| Reset | Oct 21, 2019 | |
| Release | Oct 24, 2019 | |
| Reset | Nov 14, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 2, 2019 | Oct 21, 2019 | |||
| Oct 24, 2019 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C544151 | jinfukang |
| D000068437 | Pemetrexed |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| XingZaoRuanJian | Drug | treated with chemotherapy |
|
|
| pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin | Drug |
|
| 21 days |
| Nov 14, 2019 |
| 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 |