Trastuzumab in HER2-positive Biliary Tract Cancer

Phase 2

Completed

• Conditions: Biliary Tract Cancer; HER-2 Protein Overexpression; Cholangiocarcinoma; HER-2 Gene Amplification
• Interventions: Drug: Trastuzumab

• Registration Number: NCT03613168
• Lead Sponsor: Changhoon Yoo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-28
• Study First Submitted QC: 2018-07-28
• Study First Posted: 2018-08-02
• Study Start: 2019-06-01
• Primary Completion: 2020-11-01
• Status Verified: 2021-01
• Study Completion: 2021-01-04
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trastuzumab plus Gem/Cis	Trastuzumab	Gemcitabine 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of