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

Zhengzhou University

Status and phase: Unknown; Phase 2

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03521219

AHEAD-HNP050

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Apatinib

Experimental group

Description:

Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Treatment:

Drug: Apatinib