Biliary Tract Cancer, Cholangiocarcinoma, HER-2 Gene Amplification, HER-2 Protein Overexpression
Conditions
Keywords
Cholangiocarcinoma, Biliary Tract Cancer, Trastuzumab
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.
Interventions
DRUGTrastuzumab
Trastuzumab plus gemcitabine/cisplatin
Sponsors
Changhoon Yoo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC with histological diagnosis 2. At least one measurable(per RECIST 1.1) lesion 3. Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+ 4. ECOG Performance status 0 or 1 5. At least 3 months for life expectancy Common inclusion criteria 6. Men or women over 19 years at time of signing ICF 7. Signed Informed Consent Form
Exclusion criteria
8. Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted) 9. Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to ≥ Grade 2) 10. 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 11. ANC \< 1.5 × 109/L, or Platelet \< 100 × 109/L 12. 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 13. Creatinine clearance \< 60 mL/min(calculated using the Cockcroft-Gault formula) Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months | Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Adverse events | 2 years | Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | Time between the initiation of chemotherapy and disease progression or death |
| Overall survival | 2 years | Time between the initiation of chemotherapy and any cause of death |
Countries
South Korea
Outcome results
None listed