Apatinib for Advanced Biliary Carcinoma

Sponsor
Fudan University
Study ID
NCT03427242
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase II open-label, one-arm, single-center study of apatinib for eligible patients with advanced biliary tract carcinoma after the first-line treatment failure. A total of 55 patients is planned for enrollment. The time for enrollment is from Nov 2017 to Nov 2020, the the follow-up will be ended after Nov 2021. Patients in the study would receive oral apatinib 500-750mg qd until progression of disease.

Key Dates

Start date
Nov 1, 2017
Status verified
Nov 2017
Primary completion
Oct 31, 2021
Completion
Oct 31, 2022

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm
    oral apatinib

Primary Outcome Measure

PFS [ Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months ]

Central Contacts

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