A Study of Second-line Treatment With Apatinib in Patients With Advanc

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

Currently recruiting.

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https://clinicaltrials.gov/ct2/show/NCT03251443

Purpose
The purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. The primary endpoint of this study is objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

Condition Intervention Phase
Intrahepatic Cholangiocarcinoma
Second-line Treatment
Drug: Apatinib
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Intrahepatic Cholangiocarcinoma
U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
Progression-free Survival (PFS) [ Time Frame: six months ]
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.

Objective Response Rate (ORR) [ Time Frame: one year ]
Disease Control Rate (DCR) [ Time Frame: one year ]

Secondary Outcome Measures:
Overall Survival (OS) [ Time Frame: two years ]
Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause

Incidence of Treatment-Emergent Adverse Event [ Time Frame: one year ]

Estimated Enrollment: 30
Actual Study Start Date: August 8, 2017
Estimated Study Completion Date: September 8, 2018
Estimated Primary Completion Date: August 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apatinib
A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
Drug: Apatinib
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Other Name: Apatinib mesylate tablets

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
Life expectancy of at least 12 weeks;
Subjects who understand and voluntarily signed a written informed consent form.
Exclusion Criteria:

Previous locoregional therapy within 4 weeks prior to enrollment.
Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
Prepared for liver transplantation.
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).
A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
Patients with central nervous system metastases or brain metastasis
Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
Pregnant or lactating women.
Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03251443

Contacts
Contact: Jian-zhen Lin +86 18800158133 jzlin816@126.com
Contact: Wen-dan Fang netizen_s@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jian-zhen Lin, Doctor +86-188-0015-8133 jzlin816@126.com
Contact: Xiao-Bo Yang, Doctor +86-138-1167-5126 yangxiaobo67@pumch.cn
Principal Investigator: Hai-Tao Zhao, Doctor
Sponsors and Collaborators
Peking Union Medical College Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Study Chair: Hai-tao Zhao Peking Union Medical College Hospital (PUMCH)
More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03251443 History of Changes
Other Study ID Numbers: JS-1392
Study First Received: August 14, 2017
Last Updated: August 15, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 17, 2017