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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yangzhengxiaoji Capsule | Experimental | Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po |
|
| Placebo Capsule | Placebo Comparator | Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yangzhengxiaoji Capsule | Drug | Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle. Yangzhengxiaoji Capsule four granules t.i.d po. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-Lung scale | 84day | |
| Lung Cancer Symptom Scale | 84day |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-cancer drugs common grading evaluation of adverse reaction | 84day | |
| Completion of chemotherapy | 84 day | |
| Objective response rate |
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Inclusion criteria:
Histology and/or cytology confirmed stage Ⅳ NSCLC patients;
With at least one measurable solid tumor (RECIST standard version 1.1): tumor >=10 mm in diameter on CT or MRI images, or lymph node >=15 mm in diameter on CT or MRI images;
Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival > 3 months;
Age: 18-70 years;
Normal organ function:
Bone marrow: neutrophils (ANC) count>=1.5×10^9/L, Platelets count>=100×10^9/L, hemoglobin>=90g/L;Renal function, serum creatinine<=1.5 mg/dl, and/or creatinine clearance or>=60 ml/min; Liver function: total serum bilirubin levels <= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT >=5 times ULN;
For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;
Informed consent.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligang Xing, M.D. | Contact | 18053100188 | xinglg@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, PhD | Shandong Cancer Hospital and Institute | Study Chair |
| Jie Wang, PhD | Biejing Cancer Hospital | Study Chair |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Placebo Capsule | Drug | Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle. Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle. Placebo Capsule four granules t.i.d po. |
|
| 84day |
| Progression-free survival | 84 day |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |