Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.
Interventions
DRUGApatinib
Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18-65 years; 2. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; 3. Estimated survival time \> 3 months; 4. Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis; 5. Previous first-line GP programmes failed, or were not able to withstand first-line treatment; 6. At least one measurable lesion \[spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)\], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1); 7. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL，TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal； 8. No serious history of drug allergy； 9. Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.
Exclusion criteria
1. Patients have received targeted therapy； 2. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)； 3. Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment； 4. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours\>1.0 g； 5. Pregnant or lactating women； 6. History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer; 7. The researchers judged other conditions that might affect clinical research and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 1 month | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 24 month | Time from start of treatment until the first documented event of symptomatic progression or death. |
| Objective Response Rate(ORR) | 1 month, 3 month, 6 month | Proportion of patients with reduction in tumor burden of a predefined amount |
| Overall Survival | 36 month | from start of treatment to death from any cause, or last known date of survival |
Countries
China
Contacts
Primary ContactWei He
Outcome results
None listed