NCT03251443

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

December 2, 2020

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

August 14, 2017

Last Update Submit

November 30, 2020

Conditions

Intrahepatic CholangiocarcinomaSecond-line Treatment

Outcome Measures

Primary Outcomes (3)

  • 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

  • Disease Control Rate (DCR)

    one year

Secondary Outcomes (2)

  • Overall Survival (OS)

    two years

  • Incidence of Treatment-Emergent Adverse Event

    one year

Study Arms (1)

Apatinib

EXPERIMENTAL

A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Drug: Apatinib

Interventions

ApatinibDRUG

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

Also known as: Apatinib mesylate tablets
Apatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Hai-tao Zhao

    Peking Union Medical College Hospital (PUMCH)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

August 8, 2017

Primary Completion

March 8, 2019

Study Completion

May 8, 2019

Last Updated

December 2, 2020

Record last verified: 2019-07

Locations

CN(1)