Advanced Hilar Cholangiocarcinoma
Conditions
Interventions
Case series:Paclitaxel (180mg / m2) and gemcitabine (1000mg / m2) were used during TACE, once every 4-6 weeks. Apatinib mesylate tablets were orally administered 5 days after operation, 250 mg, QD.
Sponsors
Department of Interventional medicine, the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old male and female; 2. ECoG physical status score 0-2; 3. Expected survival time >=12 weeks; 4. Patients with unresectable hilar cholangiocarcinoma confirmed by histology or cytology, and patients with obstructive jaundice who need interventional drainage treatment, bilirubin level is lower than 3 times of the upper limit of normal value; 5. Patients refused or could not tolerate systemic chemotherapy; 6. At least one measurable lesion [spiral CT / MRI scan >=10 mm (CT scan slice thickness not greater than 5 mm)] (RECIST version 1.1); 7. The function of important organs meets the following requirements: (1) absolute neutrophil count (ANC) >=1.5x10^9/L; (2) platelet >=75x10^9/L; (3) hemoglobin >=8 g/dl; (4) serum albumin >=2.8 g/dl; (5) bilirubin =50ml/min (see Annex III); (7) thyroid function Normal; (8) The left ventricular ejection fraction (LVEF) measured by 2D echocardiography was more than 50%; 8. No serious complications, such as hypertension, coronary heart disease and mental history, and no serious allergic history; 9. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test before enrollment; 10. Subjects voluntarily participated in the study. The informed consent form was signed, good compliance, and be able to complete followed up.
Exclusion criteria
Exclusion criteria: 1. Patients with apatinib contraindications (active bleeding, ulcer, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, cardiac insufficiency of grade III-IV, severe liver and kidney dysfunction, etc.); 2. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5; 3. urine routine examination indicated that urine protein was >=+ +, or 24-hour urine protein was >=1.0 g; 4. Pregnant or lactating women; 5. Other malignant tumors were diagnosed within 5 years before the first use of the study drug, except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical cancer in situ and / or breast cancer after effective treatment; 6. Patients prone to infection and poor blood glucose control; 7. He has received targeted therapy or other anti-tumor treatment other than those specified in the protocol; 8. The researcher judges other situations that may affect the clinical study and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR; | — |
Countries
China
Contacts
Public ContactXuhua Duan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed