Overview

A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma

Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
0
Participant gender:
All
Summary
The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Apatinib
Criteria
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.