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CholangiocarcinomaPhase 2BILHERNCT03613168

Trastuzumab in HER2-positive Biliary Tract Cancer

A Phase 2 study testing Trastuzumab in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Changhoon Yoo at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2019to 4 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • At least 3 months for life expectancy Common inclusion criteria
  • Men or women over 19 years at time of signing ICF
  • Signed Informed Consent Form

Who cannot join

  • 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
  • Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other exclusion criteria related to IP
Show all 22Show fewer
  • 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
  • Clinically significant Hearing impairment Common exclusion criteria
  • 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
  • Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
  • Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least 2 weeks after palliative radiotherapy for bone metastasis and recovery from the effects of radiation will be accepted.)
  • Major surgery within 4 weeks prior to initiation of study treatment
  • History of HIV and active HBV or HCV
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer

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.

Being tested
Trastuzumab
Keywords
Cholangiocarcinoma, Biliary Tract Cancer, Trastuzumab
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03613168
Study groupRoleWhat they receive
Trastuzumab plus Gem/CisExperimentalGemcitabine 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
Receives: Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

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

    Measured: 6 months

  2. Adverse events

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

    Measured: 2 years

Secondary outcomes (2)

  1. Progression-free survival

    Time between the initiation of chemotherapy and disease progression or death

    Measured: 2 years

  2. Overall survival

    Time between the initiation of chemotherapy and any cause of death

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start1 Jun 2019
  3. Primary completion1 Nov 2020
  4. Study completion4 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03613168
Sponsor's protocol ID
BTC-HER2
Acronym
BILHER
Status last verified
Jan 2021
First submitted
28 Jul 2018
Last updated
5 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Changhoon Yoo at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03613168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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