NCT02558959

Brief Summary

This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

September 21, 2015

Last Update Submit

February 10, 2018

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    PFS

    within 1 year

Secondary Outcomes (1)

  • Overall Survival

    within 1 year

Study Arms (2)

Irinotecan and Capecitabine

EXPERIMENTAL

irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w

Drug: IrinotecanDrug: Capecitabine

Irinotecan

ACTIVE COMPARATOR

irinotecan 180mg/m2 d1, q2w

Drug: Irinotecan

Interventions

IrinotecanDRUG
IrinotecanIrinotecan and Capecitabine
CapecitabineDRUG
Irinotecan and Capecitabine

Eligibility Criteria

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

You may qualify if:

  • Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
  • Age 18 years or older
  • Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
  • Karnofsky performance status (KPS) of at least 70%
  • Adequate renal function, adequate hepatic function, adequate bone marrow function

You may not qualify if:

  • The presence of any severe concomitant disease that could interrupt the planned treatment
  • Intractable pain
  • Hypersensitivity to study drugs
  • Serious cardiovascular disease
  • If female, pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

IrinotecanCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cancer Biotherapy Center

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

September 1, 2015

Primary Completion

September 30, 2017

Study Completion

December 31, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

CN(1)