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

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

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

Conditions
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Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib<br>Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops. | Drug: Apatinib<br>* Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Time from start of treatment until the first documented event of symptomatic progression or death. | 24 month | 
| Objective Response Rate(ORR) | Proportion of patients with reduction in tumor burden of a predefined amount | 1 month, 3 month, 6 month | 
| Overall Survival | from start of treatment to death from any cause, or last known date of survival | 36 month |