Phase II single-arm study of Trastuzumab combination with Cisplatin and Gemcitabine as first-line therapy in the HER-2 positive Advanced CholangioCArcinoma

Phase 2

Recruiting

• Conditions: Advanced biliary tract cancersHER-2 positiveFirst-line therapy; Cholangiocarcinoma; Gallbladder Cancer; Biliary Tract Cancers; Oncogene Protein HER-2; Trastuzumab; Cisplatin; Gemcitabine; Cancer Chemotherapy Agent; Combined Antineoplastic Agents

• Registration Number: TCTR20220328005
• Lead Sponsor: Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Last Update Posted: 19 August 2024
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 33

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

1. Ampullary cancer
2. Mixed histology e.g. HCC, SCC, NET, small cell carcinoma
3. HER2 activating mutation without HER-2 amplification

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate at 9, 18 and 27 weeks RECIST criteria version 1.1

Secondary Outcome Measures

Name	Time	Method
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-5