Back to resultsA Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apatinib
Arm Description
Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Outcomes
Primary Outcome Measures
Disease Control Rate (DCR)
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
Secondary Outcome Measures
Progression-free Survival
Time from start of treatment until the first documented event of symptomatic progression or death.
Objective Response Rate(ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
Overall Survival
from start of treatment to death from any cause, or last known date of survival
Full Information
NCT ID
NCT03521219
First Posted
April 21, 2018
Last Updated
May 9, 2018
Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03521219
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib
Arm Type
Experimental
Arm Description
Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Time from start of treatment until the first documented event of symptomatic progression or death.
Time Frame
24 month
Title
Objective Response Rate(ORR)
Description
Proportion of patients with reduction in tumor burden of a predefined amount
Time Frame
1 month, 3 month, 6 month
Title
Overall Survival
Description
from start of treatment to death from any cause, or last known date of survival
Time Frame
36 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei He
Phone
18638553286
Email
hewei726@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei He
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei He
12. IPD Sharing Statement
Learn more about this trial
A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma
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