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Trastuzumab in HER2-positive Biliary Tract Cancer

NCT03613168 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-01-05

No results posted yet for this study

Summary

Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of current standard gemcitabine plus cisplatin.

Conditions

  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • HER-2 Protein Overexpression
  • HER-2 Gene Amplification

Interventions

DRUG

Trastuzumab

Trastuzumab plus gemcitabine/cisplatin

Sponsors & Collaborators

  • Changhoon Yoo

    lead OTHER

Principal Investigators

  • Changhoon Yoo, MD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-11-01
Completion
2021-01-04

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

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 NCT03613168 on ClinicalTrials.gov