BILHER: Trastuzumab in HER2-positive Biliary Tract Cancer

• Sponsor: Changhoon Yoo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03613168
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma; Biliary Tract Cancer; HER-2 Protein Overexpression; HER-2 Gene Amplification	Drug: Trastuzumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer
• Actual Study Start Date: Jun 1, 2019
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Jan 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trastuzumab plus Gem/Cis 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	Drug: Trastuzumab; Trastuzumab plus gemcitabine/cisplatin

Outcome Measures

Primary Outcome Measures

1. Response rate [6 months]

   Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

2. 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

1. Progression-free survival [2 years]

   Time between the initiation of chemotherapy and disease progression or death

2. Overall survival [2 years]

   Time between the initiation of chemotherapy and any cause of death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

1. Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)

2. Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to ≥ Grade 2)

3. 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

4. ANC < 1.5 × 109/L, or Platelet < 100 × 109/L

5. 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

6. Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other exclusion criteria related to IP

7. 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

8. LVEF < 50% (calculated by cardiac sonography or MUGA)

9. Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy

10. Chronic or high-dose corticosteroid treatment

11. Clinically significant Hearing impairment Common exclusion criteria

12. History or evidence of CNS metastases

13. Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray

14. Hearing loss

15. Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)

16. Pregnant or lactating females

17. Sexually active fertile subjects without contraception

18. Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment

19. 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.)

20. Major surgery within 4 weeks prior to initiation of study treatment

21. History of HIV and active HBV or HCV

22. Previously identified allergy or hypersensitivity to components of the study treatment formulations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Changhoon Yoo

Investigators

• Principal Investigator: Changhoon Yoo, MD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Changhoon Yoo, Assistant professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03613168
• Other Study ID Numbers: BTC-HER2
• First Posted: Aug 2, 2018
• Last Update Posted: Jan 5, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Changhoon Yoo, Assistant professor, Asan Medical Center: Cholangiocarcinoma; Biliary Tract Cancer; Trastuzumab
• Additional relevant MeSH terms: Cholangiocarcinoma; Biliary Tract Neoplasms; Trastuzumab

Study Results

No Results Posted as of Jan 5, 2021