Clinical trial NCT03613168: Trastuzumab in HER2-positive Biliary Tract Cancer
Official title: The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Biliary Tract Cancer
HER-2 Protein Overexpression
HER-2 Gene Amplification
Keywords: Cholangiocarcinoma
Biliary Tract Cancer
Trastuzumab
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria related to IP
14. 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
15. LVEF \< 50% (calculated by cardiac sonography or MUGA)
16. Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
17. Chronic or high-dose corticosteroid treatment
18. Clinically significant Hearing impairment Common exclusion criteria
19. History or evidence of CNS metastases
20. Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
21. Hearing loss
22. Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)
23. Pregnant or lactating females
24. Sexually active fertile subjects without contraception
25. Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
26. 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.)
27. Major surgery within 4 weeks prior to initiation of study treatment
28. History of HIV and active HBV or HCV
29. Previously identified allergy or hypersensitivity to components of the study treatment formulations

Primary outcomes:
measure: Response rate
timeFrame: 6 months
measure: Adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Changhoon Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: