Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

Sponsor
AstraZeneca
Study ID
NCT05557838
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous infusion)
  • Tremelimumab — DRUG
    Tremelimumab IV (intravenous infusion)

Study Details

This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.

Key Dates

Start date
Feb 22, 2023
Status verified
Feb 2025
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1
    durvalumab in combination with tremelimumab
  • Experimental: cohort 2
    durvalumab in combination with tremelimumab

Primary Outcome Measure

≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1 [ Time Frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months ]

Central Contacts

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