NCT03521219

Brief Summary

The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

February 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

April 21, 2018

Last Update Submit

May 9, 2018

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease Control Rate (DCR)

    the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease

    1 month

Secondary Outcomes (3)

  • Progression-free Survival

    24 month

  • Objective Response Rate(ORR)

    1 month, 3 month, 6 month

  • Overall Survival

    36 month

Study Arms (1)

Apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

ApatinibDRUG

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

Apatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 years;
  • Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
  • Estimated survival time \> 3 months;
  • Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis;
  • Previous first-line GP programmes failed, or were not able to withstand first-line treatment;
  • At least one measurable lesion \[spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)\], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1);
  • Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL，TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal；
  • No serious history of drug allergy；
  • Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.

You may not qualify if:

  • Patients have received targeted therapy；
  • 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)；
  • Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；
  • Urine routine showed that urine protein ≥++ or the urine protein in 24 hours\>1.0 g；
  • Pregnant or lactating women；
  • History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer;
  • The researchers judged other conditions that might affect clinical research and the outcome of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Wei He

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei He

CONTACT

18638553286hewei726@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician of Oncology

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 11, 2018

Study Start

February 7, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

CN(1)