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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of this study was to evaluate the effectiveness and safety of apatinib combined with docetaxel in NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib plus docetaxel | Experimental | apatinib combine with docetaxel, 4~6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | apatinib, at a dose of 250 mg daily,Treatment was continued until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | Proportion of patients with reduction in tumor burden of a predefined amount | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival (PFS) | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. | 12 month |
| disease control rate (DCR) |
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Inclusion Criteria:
1. Male or female patients, age: ≥ 18 years of age;
2. Pathologically diagnosed late (stage IIIB, stage IV, see Annex 1) non-squamous non-small cell lung cancer with measurable lesions (CT scan of tumor lesion longer than 10 mm in diameter, shorter than 15 CT scan of lymph nodes mm, the scanning layer thickness is not more than 5 mm;
3. Previous drug treatment consisted of a platinum-based chemotherapy regimen (> 1 chemotherapy regimen) for relapse or failure of treatment.
4. The main organs function properly, that is, within 14 days prior to the relevant indicators meet the following requirements:(1) a. Hemoglobin (HB) ≥90 g / L; (no blood transfusion within 14 days):b. neutrophil count (ANC) ≥ 1.5 × 109 / L; c. Platelet count (PLT) ≥80 × 109 / L;(2) biochemical tests to meet the following criteria:a. Total bilirubin (TBIL) <1.5?ULN (upper limit of normal);b. Blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
5. Sign the inform consent form with good compliance.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiyuan Ma, M.D | Contact | 868172246171 | angenpn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daiyuan Ma, M.D | Affiliated Hospital of North Sichuan Medical College | Principal Investigator |
| xin hu, M.D. | Nanchong Central Hospital | Study Director |
| xiangdong fang, M.d. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of North Sichuan Medical College | Recruiting | Nanchong | Sichuan | 600000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31261514 | Derived | Jiang Q, Zhang NL, Ma DY, Tan BX, Hu X, Fang XD. Efficacy and safety of apatinib plus docetaxel as the second or above line treatment in advanced nonsquamous NSCLC: A multi center prospective study. Medicine (Baltimore). 2019 Jun;98(26):e16065. doi: 10.1097/MD.0000000000016065. |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks for 4~6 cycles. |
|
Disease Control Rate (DCR) and Clinical Benefit Rate (CBR) are defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.
| 6 month |
| 6-month overall survival rate | 6-month overall survival rate | 6 month |
| Dazhou Central Hospital |
| Study Director |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |