NCT03613168

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

July 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

July 28, 2018

Last Update Submit

January 4, 2021

Conditions

CholangiocarcinomaBiliary Tract CancerHER-2 Protein OverexpressionHER-2 Gene Amplification

Keywords

CholangiocarcinomaBiliary Tract CancerTrastuzumab

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    6 months

  • Adverse events

    Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03

    2 years

Secondary Outcomes (2)

  • Progression-free survival

    2 years

  • Overall survival

    2 years

Study Arms (1)

Trastuzumab plus Gem/Cis

EXPERIMENTAL

Gemcitabine 1,000 mg/m2 Day 1 and Day 8, every 3 weeks Cisplatin 25 mg/m2 Day 1 and Day 8, every 3 weeks Trastuzumab, every 3 weeks, 8 mg/kg at first cycle then, 6 mg/kg

Drug: Trastuzumab

Interventions

TrastuzumabDRUG

Trastuzumab plus gemcitabine/cisplatin

Trastuzumab plus Gem/Cis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC with histological diagnosis
  • At least one measurable(per RECIST 1.1) lesion
  • Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+
  • ECOG Performance status 0 or 1
  • Men or women over 19 years at time of signing ICF
  • Signed Informed Consent Form

You may not qualify if:

  • Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)
  • Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to ≥ Grade 2)
  • History of malignancy other than CCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as carcinoma in situ or thyroid papillary carcinoma Hematology, chemistry or organ function
  • ANC \< 1.5 × 109/L, or Platelet \< 100 × 109/L
  • Total bilirubin \> 1.5 × ULN; or AST/ ALT \> 2.5 × ULN (or if the tumor has expanded into the liver, \> 5 × ULN); or, alkaline phosphatase \> 2.5 × ULN (or \> 5 × if the tumor has expanded into the liver, or \> 10 × ULN if the tumor has expanded into the brain without liver,); or albumin \< 2.5 g/dL
  • History of proved congestive heart failure; angina with medication; evidence of transmural myocardial infarction on ECG; uncontrolled hypertension(systolic\> 180 mmHg or diastolic\> 100 mmHg); clinically significant heart valve disease; uncontrolled arrhythmia
  • LVEF \< 50% (calculated by cardiac sonography or MUGA)
  • Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
  • Chronic or high-dose corticosteroid treatment
  • History or evidence of CNS metastases
  • Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
  • Hearing loss
  • Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)
  • Pregnant or lactating females
  • Sexually active fertile subjects without contraception
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

CholangiocarcinomaBiliary Tract Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Changhoon Yoo, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 28, 2018

First Posted

August 2, 2018

Study Start

June 1, 2019

Primary Completion

November 1, 2020

Study Completion

January 4, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)