Trastuzumab in HER2-positive Biliary Tract Cancer

NCT ID: NCT03613168

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-01-04

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.

Conditions

Cholangiocarcinoma; Biliary Tract Cancer; HER-2 Protein Overexpression; HER-2 Gene Amplification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

Trastuzumab plus gemcitabine/cisplatin

Interventions

Trastuzumab

Trastuzumab plus gemcitabine/cisplatin

Intervention Type: DRUG

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

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

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

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhoon Yoo

OTHER

Sponsor Role: lead

Responsible Party

Changhoon Yoo

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Changhoon Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BTC-HER2

Identifier Type: -

Identifier Source: org_study_id