Status:
UNKNOWN
Apatinib for Advanced Biliary Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 pl...
Eligibility Criteria
Inclusion
- Patients age between 18 and 70 years
- Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC
- Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine).
- At least one measurable lesion as defined by RECIST 1.1
- An Eastern Cooperative Oncology Group performance status of 0 to 2
- Life expectancy ≥ 12 weeks
- 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.
- 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
- Women of reproductive age need to take effective contraceptive measures
Exclusion
- With other malignant tumor in 5 years，except for cured cervical carcinoma in situ or basal cell carcinoma.
- Uncontrolled blood pressure on medication (140/90 mmHg); patients with \> Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction
- Symptomatic brain or meningeal metastasis
- History of uncontrolled seizures, central nervous system dysfunction or mental disorder
- Uncontrolled pleural or peritoneal effusion
- Undergoing dialysis
- Severe or uncontrolled infection
- With multiple factors that affecting oral administration
- Abnormal coagulation function or those receiving thrombolytics or anticoagulants
- Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
- Participation in other drug clinical trials within 4 weeks
- Weight below 40kg
- urine protein ≥2+
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03427242
Start Date
November 1 2017
End Date
October 31 2022
Last Update
February 9 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032