Advanced biliary tract cancers HER-2 positive First-line therapy Cholangiocarcinoma Gallbladder Cancer Biliary Tract Cancers Oncogene Protein HER-2 Trastuzumab Cisplatin Gemcitabine Cancer Chemotherapy Agent Combined Antineoplastic Agents
Conditions
Interventions
1. Trastuzumab Loading 8 mg/kg + NSS 250 mL IV drip in 90 min then 6 mg/kg + NSS 250 mL IV drip in 30 min on day 1 every 3 weeks, up to 8 cycles
2. Cisplatin 25 mg/m2 + NSS 250 mL IV drip in 1 hr on d
Experimental Drug
Trastuzumab
Sponsors
Khon Kaen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years 2. Radiographic evidence of advanced cholangiocarcinoma or gallbladder cancer not amenable for curative treatment 3. Histology-confirmed diagnosis 4. HER-2 IHC 2-3+ AND FISH positive 5. No previous systemic therapy except last adjuvant chemotherapy at least 6 months 6. ECOG performance 0-1 7. Measurable lesion 7. Adequate organ function e.g. CrCl at least 50 mL/min, LVEF at least 50%
Exclusion criteria
Exclusion criteria: 1. Ampullary cancer 2. Mixed histology e.g. HCC, SCC, NET, small cell carcinoma 3. HER2 activating mutation without HER-2 amplification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate at 9, 18 and 27 weeks RECIST criteria version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival at 9, 18 and 27 weeks RECIST criteria version 1.1,Time to progression at 9, 18 and 27 weeks RECIST criteria version 1.1,Overall survival Date from cycle 1 day 1 to death Death,Quality of life During intervention EQ-5D-5L | — |
Countries
Thailand
Contacts
Public ContactThanachai Sanlung
Srinagarind comprehensive cancer center
Outcome results
None listed