HIMALAYA

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: JPRN-jRCT2080223793
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

HCC based on histopathological confirmation

- No prior systemic therapy for HCC

- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C

- Child-Pugh Score class A

- ECOG performance status of 0 or 1 at enrollment

Exclusion Criteria

- Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy

- Clinically meaningful ascites

- Main portal vein thrombosis

- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months

- HBV and HVC co-infection, or HBV and Hep D co-infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified