Overview

Apatinib for Advanced Biliary Carcinoma

Status:
Recruiting

Trial end date:
2022-10-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fudan University

Treatments:

Apatinib

Criteria

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+