Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC

Sponsor
AstraZeneca
Study ID
NCT05557838
Phase
PHASE3
Status
Active Not Recruiting

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) CTLA-4 inhibitor

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

First listed
Sep 28, 2022
Start date
Feb 15, 2023
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
214 participants (actual)
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 44months ]

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