Biliary Tract Neoplasms
Conditions
Keywords
biliary tract carcinoma, apatinib
Brief summary
This is a phase II open-label, one-arm, single-center study of apatinib for eligible patients with advanced biliary tract carcinoma after the first-line treatment failure. A total of 55 patients is planned for enrollment. The time for enrollment is from Nov 2017 to Nov 2020, the the follow-up will be ended after Nov 2021. Patients in the study would receive oral apatinib 500-750mg qd until progression of disease.
Interventions
DRUGApatinib
oral apatinib 750mg qd
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
apatinib
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients age between 18 and 70 years 2. Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC 3. Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine). 4. At least one measurable lesion as defined by RECIST 1.1 5. An Eastern Cooperative Oncology Group performance status of 0 to 2 6. Life expectancy ≥ 12 weeks 7. For those who received other anti-tumor treatment, the damage should have been restored, with the time interval from last dose of nitroso or mitomycin≥6 weeks and interval from last dose of other cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥4 weeks. 8. Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood ANC count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin \< 1.5 x ULN, ALT and AST\< 2.5 x ULN(\< 5 x ULN for patients with live metastasis), serum creatinine≤1 x ULN，endogenous creatinine clearance rate \>50ml/min 9. Women of reproductive age need to take effective contraceptive measures
Exclusion criteria
1. With other malignant tumor in 5 years，except for cured cervical carcinoma in situ or basal cell carcinoma. 2. Uncontrolled blood pressure on medication (140/90 mmHg); patients with \> Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction 3. Symptomatic brain or meningeal metastasis 4. History of uncontrolled seizures, central nervous system dysfunction or mental disorder 5. Uncontrolled pleural or peritoneal effusion 6. Undergoing dialysis 7. Severe or uncontrolled infection 8. With multiple factors that affecting oral administration 9. Abnormal coagulation function or those receiving thrombolytics or anticoagulants 10. Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months 11. Participation in other drug clinical trials within 4 weeks 12. Weight below 40kg 13. urine protein ≥2+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | from the time signing of ICF until the date of death from any cause, assessed up to 48 months | overall survival |
Countries
China
Contacts
Primary ContactChenchen Wang, MD
Outcome results
None listed