advanced cholangiocarcinoma
Conditions
Interventions
Case series:Apatinib
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Histologically or cytologically confirmed diagnosis of unresectable,recurrent or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, hilar cholangiocarcinoma and distal cholangiocarcinoma); 3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version; 4. Patients intoleranting or unwilling to receive chemotherapy or recurrence or metastasis after DET-TACE or c-TACE 5. ECOG(Eastern Cooperative Oncology Group) :0~2;patients must have a life expectancy of at least 3 months 6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/L, PLT>50×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value (Liver metastasis: <5×ULN), and CR=1.25 ×ULN 7. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 8. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Previous (5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ; 2. Uncontrollable ascites, hepatic encephalopathy or bleeding of esophageal and gastric fundus varices; 3. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); 4. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%); 5. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 6. Previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood = ( ++ ) not in group; fecal occult blood (+), requiring gastroscopy; 7. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before screening; 8. Patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment; 9. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 10. Pregnant and lactating women; 11. Patients infected with union HIV; 12. Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year survival rate ;ORR;DCR; | — |
Countries
China
Contacts
Public ContactJunhui Sun
The First Affiliated Hospital Zhejiang University
Outcome results
None listed