metastatic esophageal squamous cell carcinoma
Conditions
Interventions
CFregimen:cisplatin plus 5- fluorouracil
TP regimen:paclitaxel plus cisplatin
TN regimen:paclitaxel plus nedaplatin
Sponsors
Nanyang Central Hospital, Henan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-70 years; 2. Esophageal squamous cell carcinoma confirmed by endoscopic examination and biopsy of esophageal local lesions; 3. ECOG score: 0-1 points; 4.life expectancy greater than 12 weeks; 5. Tissue specimens can be provided for further biological target detection; 6. the level of organ function must conform to the following requirements: (1) HB = 90 g/L blood routine examination; (without blood transfusion within 14 days); ANC = 1.5*10^9/L; PLT = 80*10^9/L; (2) ALB = 30g/biochemical tests (not losing ALB within 14 days) of ALT and AST<2.5*ULN (you present liver metastasis ALT and AST<5*ULN); TBIL = 1.5; normal renal function; 7. Doppler ultrasound assessment of left ventricular ejection fraction (LVEF) than low limit of normal (50%); 8. to be able to understand this study and have signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) in 5 years or at the same time suffering from other malignancies; (2) Those who are severely allergic to the study of chemotherapy drugs,; (3) serious cachexia, cannot eat, can not tolerate chemotherapy; (4) during the screening, the first time before the drug delivery of unexplained fever and temperature >38.5? (after the researchers judged, Fever and tumor-related persons may enter the group); (5) patients with any severe and/or uncontrolled disease, including: a. Patients with high blood pressure and antihypertensive drugs could not get good control (systolic pressure =150 mmHg, diastolic pressure =100mmhg); b. Suffering from myocardial ischemia or myocardial infarction, Arrhythmia (including qtc=480ms) and = 2-level congestive heart failure (New York Heart Association (NYHA) grade) C. Active or uncontrolled severe infection (=CTC AE v4.0=2-level infection) d. Renal failure requires hemodialysis or peritoneal dialysis; E. A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency, or organ transplant recipients; Diabetes patients with poor glycemic control (fasting blood glucose (FBG) >10mmol/l); Patients with epilepsy and need to be treated; (6) At present, there are intestinal obstruction (including incomplete intestinal obstruction) and other digestive diseases or the researchers determined that may cause gastrointestinal bleeding, patients with perforation or obstruction; (7) in the first 4 weeks before the group, there were nonunion wounds, ulcers or fractures, and (8) those with central nervous system metastasis; (9) Having a history of psychotropic substance abuse and being unable to abstain or have mental disorders; (10) primary treatment or postoperative recurrence of metastasis but after the anti-tumor therapy; (11) According to the researcher's judgment, there are serious harm to patients with safety or affect the patient to complete the study of the accompanying disease;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;Toxicity reaction of chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR; | — |
Countries
China
Contacts
Public ContactZhonghai Ren
Outcome results
None listed