Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma

The First Affiliated Hospital of Zhengzhou University1 site in 1 country30 target enrollmentFebruary 7, 2018

InterventionsApatinib

Overview

The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.

Registry

clinicaltrials.gov

Start Date

February 7, 2018

End Date

November 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

The First Affiliated Hospital of Zhengzhou University

Responsible Party

Principal Investigator

Wei He

Deputy Chief Physician of Oncology

The First Affiliated Hospital of Zhengzhou University

•Ages 18-65 years;
•Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
•Estimated survival time \> 3 months;
•Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis;
•Previous first-line GP programmes failed, or were not able to withstand first-line treatment;
•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);
•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；
•No serious history of drug allergy；
•Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.

•Patients have received targeted therapy；
•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)；
•Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；
•Urine routine showed that urine protein ≥++ or the urine protein in 24 hours\>1.0 g；
•Pregnant or lactating women；
•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;
•The researchers judged other conditions that might affect clinical research and the outcome of the study.