Clinical trial NCT03521219: A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma
Official title: Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: 1 month
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 24 month
measure: Objective Response Rate(ORR)
timeFrame: 1 month, 3 month, 6 month
measure: Overall Survival
timeFrame: 36 month
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Wei He
role: PRINCIPAL_INVESTIGATOR
References: