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

Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

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).

Study Overview

• Status: Completed
• Conditions: Intrahepatic Cholangiocarcinoma; Second-line Treatment
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Apatinib mesylate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR)		one year
Progression-free Survival (PFS)	A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.	six months
Objective Response Rate (ORR)		one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause	two years
Incidence of Treatment-Emergent Adverse Event		one year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Study Chair: Hai-tao Zhao, Peking Union Medical College Hospital (PUMCH)

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): May 8, 2019

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: JS-1392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No