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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251443
• Other study ID #: JS-1392
• Status: Completed
• Phase: Phase 2
• Start date: August 8, 2017
• Est. completion date: May 8, 2019

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Second-line Treatment

Intervention

Drug:
• Apatinib
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Objective Response Rate (ORR)		one year
Primary	Disease Control Rate (DCR)		one year
Secondary	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
Secondary	Incidence of Treatment-Emergent Adverse Event		one year