HIMALAYA

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223793

Enrollment

124

Registered

2018-02-02

Start date

2018-02-07

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Durvalumab, Tremelimumab INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety efficacy bioavailability confirmatory pharmacokinetics pharmacogenomics -	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026