esophagus cancer
Conditions
Interventions
experimental group:Duly, bead single + cisplatin + purple shirts alcohol resistance
control group:Cisplatin plus paclitaxel
Sponsors
The tumor hospital of Beijing university The tumor hospital affiliated to sun yat-sen university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. voluntary and books to sign a consent form; 2. there is no limit on the age 18 years of age or gender; 3. by the histological diagnosis of metastatic esophageal squamous carcinoma, including: (1) in the early cure metastatic esophageal cancer, without any radical surgery or radical radiation therapy may be; (2) recurrent metastatic esophageal cancer, surgery or assisted radiotherapy or radical synchronous put (change) after the treatment has spread to the recurrence, always not received systemic chemotherapy and radiotherapy target zone have measurable lesions; (3) metastatic esophageal cancer recurrence, neoadjuvant or adjuvant chemotherapy at the end of the end of drug delivery is more than 6 months; 4. metastatic esophageal lesions in clinical symptoms as a result of heavier need to adopt palliative radiotherapy, required target lesion in the wild, palliative radiotherapy and radiotherapy over more than 4 weeks (radiotherapy lesions can include but not limited to, primary tumors, bone, lymph nodes); 5. according to RECIST 1.1 standard, at least one measurable lesions, a CT scan or 10 mm; Clinical routine inspection instrument 10 mm (tumor lesions can't use caliper instrument shall be recorded as the measurement of accurately measuring the), chest X-ray 20 mm or higher;Malignant lymph nodes: pathological increase and can be measured, a single lymph node CT scans short diameter 15 mm or higher (CT scanning layer thickness is not more than 5 mm); 6. is expected to survive time 3 months or more; 7. physically ECOG ps to 0 or 1; 8. bone marrow hematopoietic function: 9.0 g/dL or higher hemoglobin, white blood cells acuity 4.0 x 109 / L, neutrophils acuity 2.0*10^9/L, platelet acuity 100.0*10^9/L; Liver and kidney function: total bilirubin acuities were 1.5*ULN, creatinine 1.0*ULN, AST/ALT acuities were 2.5 or less ULN, ALP 60 ml/min, the existence of liver metastases of subjects: AST/ALT 5.0 or less ULN; 9. growth period to take effective contraceptive measures; Compliance is good, can according to the plan with the visitor; 10. Compliance is good, can according to the plan with the visitor.
Exclusion criteria
Exclusion criteria: 1. Ever had any plan for metastatic esophageal cancer palliative chemotherapy 2. at the end of the neoadjuvant chemotherapy or postoperative adjuvant chemotherapy end of dosing 1) toxicity (such as peripheral neurotoxicity of > 1); 13. with severe cardiovascular diseases, such as difficult to control the heart failure, coronary heart disease, cardiomyopathy, arrhythmia, fails to control, high blood pressure control or the past five years of history of myocardial infarction; 14. associated with serious complications, such as the activity of the digestive tract hemorrhage, perforation, severe jaundice, gastrointestinal obstruction, active clinical infection (> 2 levels of infection standard); 15. with chronic diarrhea disease and renal insufficiency; 16. affect the cognitive or mental abnormal; 17. have other severe acute or chronic diseases; 18. pregnancy or lactation women; 19. ever participated in other clinical researchers within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| os;PFS;TTP;ORR;Quality of life; | — |
Countries
China
Contacts
Public ContactLin Sheng Ruihua Xu
Outcome results
None listed