None listed
Conditions
Interventions
Drug : Herzuma : 6mg/kg (1st), 4mg/kg (from 2nd) every 2 week, IV infusion on Day 1
Oxaliplatin : 85 mg/m2, every 2 week, Days 1-14, per oral
5-FU : 400mg/m2, every 2 week, IV on Day 1
5-FU : 2400mg/m
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with reccurent, metastatic or unresectable biliary tract cancer who are diagnosed by histological examination. (include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, Ampula of vater cancer) 2. HER2-positive cholangiocarcinoma confirmed by histological examination. HER2 positive is defined as 3+ or 2+ immunohistochemical staining and positive for HER2 gene amplification on in situ hybridization (ISH), or ERBB2 gene amplification (=6 copies) on tumor tissue NGS. 3. Patients who have received at least one systemic chemotherapy including gemcitabine + cisplatin for recurrent / metastatic / unresectable cholangiocarcinoma, and subsequently progressed radiologically. The number of previous chemotherapy for recurrent / metastatic / unresectable cholangiocarcinoma should be no more than two, and immunotherapy monotherapy (e.g., anti-PD-1 or anti-PD-L1 immune chemotherapy) is not counted as previous chemotherapy. 4. Patients who are willing and able to complete a written informed consent form for this study. 5. Patients 19 years of age or older at the time of signing the informed consent form. 6. Patients with measurable lesions according to RECIST 1.1. 7. ECOG performance score 0 or 1. 8. Patients exhibiting proper organ function. Bone marrow function ? Hemoglobin level: = 9.0 g / dl ? absolute neutrophil count: = 1,500 / µl ? Platelet count: = 10 × 104/ µl -Kidney function Creatinine: = 1.5 x upper limit of normal (UNL) or ? Creatinine clearance (Ccr) = 50 ml / min by Cockroft formula -Liver function ? Total Bilirubin: = 2.0 × UNL AST / ALT: = 2.5 × UNL (for patients with liver metastasis: = 5.0 × UNL) ? PT / aPTT =1.5 X ULN, unless the patient is receiving anticoagulant therapy and PT or PTT is within the therapeutic range of intended anticoagulant use. 9. Patients with 50% or more of LVEF and no severe valve or arrhythmia 10. Women of childbearing potential must have a negative pregnancy or urine test in the urinalysis or serology. • A female patient of childbearing potential who has a negative urine or serum pregnancy test within 72 hours prior to the first dose of study drug. If the results of a urine test are not positive or negative, a serum pregnancy test should be performed. • Women of childbearing potential must agree to use two appropriate contraceptive methods, surgical infertility, or stop intersexual sex during clinical trials and until 120 days after the last dose of study drug. A woman of childbearing potential refers to a woman who is not surgically infertile or who has not had menstruation for more than one year. • Male patients should agree to continue using the appropriate contraceptive method from the first dose of the study to 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with chemotherapy including oxaliplatin or monoclonal antibodies or small molecule inhibitors (trastuzumab, neratinib, lapatinib, etc.) targeting HER2 2. Adverse events due to chemotherapy, targeted small-molecule preparations, or drugs previously administered or administered within 2 weeks prior to Day 1 of this trial have not yet recovered (below Grade 2 or baseline levels). patient. 3. Patients with known other malignancies requiring active treatment within the last three years. The exception is cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and thyroid or cervical carcinoma treated for cure. 4. Patients known to have active central nervous system (CNS) metastases and / or carcinoma meningitis. Patients previously treated for brain metastases are clinically stable (no imaging evidence for disease progression and all neurological symptoms return to baseline levels on at least 4 weeks prior to the first dose of this drug), If there is no evidence of new or advanced brain metastasis and the steroid has not been used for at least 7 days prior to administration of the test drug, you can participate in this study. However, this exception does not apply to carcinoma meningitis, regardless of clinical stability. 5. History of the disease, treatment, or laboratory abnormalities that, in the opinion of the investigator, cause confusion in the clinical trial results, impede the patient's full participation in the trial, or involvement in the clinical trial itself is not best for the patient. 6. Cardiac dysfunction or clinically significant heart disease, including: • Clinically significant or uncontrolled heart disease (eg congestive heart failure [NYHA class 2 or higher] requiring treatment, uncontrolled hypertension or clinically significant arrhythmias) • QTcF> 470 msec or congenital QT prolongation syndrome on screening ECG • Acute myocardial infarction or unstable angina within 3 months prior to enrollment in the trial 7. Patients with known psychiatric disorders or substance abuse disorders that may interfere with compliance with clinical trial requirements. 8. Patients who are pregnant or lactating, or plan to be 2 years old during the planned clinical trial period from the screening visit to 120 days after the last dose of study drug. 9. Patients with known history of human immunodeficiency virus (HIV) (HIV-1 / 2 antibody). 10. Patients with active hepatitis B (positive HBsAg response and HBV DNA 100 ? copies / ml or hepatitis C Anti-HCV antibody positive and HCV RNA [qualitatively detected]). 11. Patients who received live vaccine within 30 days before the first scheduled dose of the test drug. 12. Active infectious diseases of the system that are not resolved. 13. Patients with a history of hypersensitivity or serious side effects to 5-FU, leucovorin, oxaliplatin or trastuzumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;disease control rate, DCR at 6 months;Overall survival, OS;Drug toxicity by CTCAE 5.0;Quality of life by patient reported outcome: EQ-5D, EORTC-QLQ-CIPN20 questionnaires | — |
Countries
Korea, Republic of
Contacts
Public ContactHye Jin Choi
Yonsei University Health System, Severance Hospital
Outcome results
None listed