Trastuzumab in HER2-positive Biliary Tract Cancer

Cholangiocarcinoma Clinical Trial

— BILHER  

Official title:

The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613168
• Other study ID #: BTC-HER2
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: January 4, 2021

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 4, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma
• HER-2 Gene Amplification
• HER-2 Protein Overexpression

Intervention

Drug:
• Trastuzumab
Trastuzumab plus gemcitabine/cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Changhoon Yoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	6 months
Primary	Adverse events	Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03	2 years
Secondary	Progression-free survival	Time between the initiation of chemotherapy and disease progression or death	2 years
Secondary	Overall survival	Time between the initiation of chemotherapy and any cause of death	2 years