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Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

NCT04722133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-10-11

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 and have shown efficacy in small basket trials. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of mFOLFOX for gemcitabine+cisplatin refractory biliary tract cancer patients.

Conditions

  • HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer

Interventions

DRUG

HERZUMA+mFOLFOX

Herzuma (Trastuzumab-pkrb) 4mg/kg after 6mg/kg loading D1 5FU 400mg/m2 bolus+2400mg/m2 infusion for 46 hrs D1 Leucovorin 200mg/m2 D1 Oxaliplatin 85mg/m2 D1 every 2 weeks

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Choong-kun Lee · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2023-06-14
Completion
2023-06-14

Countries

  • South Korea

Study Locations

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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 NCT04722133 on ClinicalTrials.gov