MedTrace Logo

A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

NCT03609489 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-09

No results posted yet for this study

Summary

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

Conditions

  • Biliary Carcinoma

Interventions

DRUG

Capecitabine

Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.

DRUG

Apatinib

Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Principal Investigators

  • Jie Ma, doctor · First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2021-06-10
Completion
2021-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609489 on ClinicalTrials.gov