| Eligibility |
Inclusion Criteria:
1. Histologically documented recurred/metastatic/unresectable biliary tract cancer,
including gallbladder cancer, intrahepatic, extrahepatic cholangiocarcinoma, or
ampulla of vater cancer.
2. Histologically confirmed HER2 positive biliary tract cancer. HER2-positive tumor was
defined as either IHC 3+ or IHC 2+ in combination with ISH +, or ERBB2 amplification
(=6 copies) by tumor tissue NGS.
3. Recurred/metastatic/unresectable biliary tract cancer patient whose disease
progression was confirmed by imaging modality after gemcitabine+cisplatin containing
1st line palliative chemotherapy regimen. Previous lines should be one or two
(immunotherapy monotherapy not counted).
4. be willing and able to provide written informed consent/assent for the trial
5. be at least 19 years of age on day of signing informed consent
6. have measurable disease based on RECIST (Response Evaluation Criteria In Solid Tumors)
version 1.1
7. have a performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group)
Performance Scale
8. demonstrate adequate organ function
9. No severe valvular or arrhythmic cardiac disease with LVEF = 50%
10. female subject of childbearing potential should have a negative urine or serum
pregnancy or be willing to use birth control
Exclusion Criteria:
1. Previous treatment history of oxaliplatin containing chemotherapy, anti-HER2 targeting
treatment (trastuzumab, neratinib, lapatinib, and etc)
2. has had a prior anti-cancer chemotherapy, targeted small molecule therapy, or
radiotherapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., =
Grade 1 or at baseline) from adverse events due to agents administered.
3. has a known additional malignancy that is progressing or requires active treatment
within 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of
the skin and thyroid cancer that has undergone potentially curative therapy or in situ
cervical cancer
4. has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
5. has known history or evidence of any disease, treatment, or laboratory results that
would inhibit the patient's participation to the study.
6. Has clinically significant cardiac disease, including congestive heart failure = NYHA
grade 2, uncontrolled hypertension, QTcF > 470 msec or QT prolong syndrome, recent
myocardiac infarction or unstable angina history
7. has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
8. is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment
9. has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
10. has known active Hepatitis B (HBsAg reactive and HBV DNA 100 =copies/ml) or Hepatitis
C (anti-HCV reactive and HCV RNA [qualitative] is detected)
11. has received a live vaccine within 30 days of planned start of study therapy.
12. has an active infection requiring systemic therapy
13. has history of severe adverse event or allergic reaction to 5-FU, leucovorin,
oxaliplatin or trastuzumab
14. need O2 supply or show dyspnea on rest due to advanced malignancy
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