esophageal cancer
Conditions
Interventions
Test Group:Apatinib, 250 mg Po qd, paclitaxel or docetaxel combined with platinum standard chemotherapy regimens, q21d, 2 to 6 cycles of chemotherapy
Control Group:paclitaxel or docetaxel combined with platinum standard chemotherapy regimens,
Sponsors
Daping Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 to 75 years; 2. ECOG PS scale 0 or 2; 3. TNM ?esophageal cancer Confirmed by histology (reference UICC/AJCC 2009); 4. Prior VEGFR inhibitor untreatment,such as sorafenib and sunitinib; 5. Blood routine test and Biochemical tests: Hemoglobin = 80g/L; Absolute neutrophil count (ANC) = 1.5×10^9/L; Platelet count= 100×10^9/L; Serum total bilirubin=1.5×ULN; Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upper limit of normal (ULN); 6. No serious heart, lung, liver, kidney disorders; Without jaundice and digestive tract obstruction; without an acute infection; 7. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. KPS scale 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man = 450 ms, for woman = 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein; 3. Urinary protein positive; 4. With potential bleeding risk including peptic ulcer and fecal occult blood (++); melena or hematemesis history in last 2 months; 5. With abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN); 6. Factors affecting the oral medication (e.g. inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.; 7. With nerve, mental illness;With severe infection; 8. Pregnant or lactating women or have fertility requirement during the study; 9. Have got other malignant tumors within last 5 years, excluding basal cell skin cancer and cervical carcinoma in situ that has already been cured; 10. Taking experimental treatment from another clinical trial study before or during treatment; 11. Other cases that the researcher found ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;safety;QoL; | — |
Contacts
Public ContactGe Wang
Daping Hospital
Outcome results
None listed