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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03251443
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : July 16, 2019
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Second-line Treatment Drug: Apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : May 8, 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

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

Secondary Outcome Measures :
  1. 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03251443

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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Jiangsu HengRui Medicine Co., Ltd.
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Study Chair: Hai-tao Zhao Peking Union Medical College Hospital (PUMCH)

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Responsible Party: Peking Union Medical College Hospital Identifier: NCT03251443     History of Changes
Other Study ID Numbers: JS-1392
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action