Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC

Sponsor
The Clatterbridge Cancer Centre NHS Foundation Trust
Study ID
NCT04268888
Phase
PHASE2/PHASE3
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab and TACE/TAE — DRUG
    Immunotherapy and TACE/TAE
  • TACE/TAE — PROCEDURE
    TACE/TAE (as per local practice)

Study Details

This study evaluates the addition of nivolumab to TACE/TAE in the treatment of patients with intermediate stage hepatocellular carcinoma. All patients will receive TACE/TAE and half will receive nivolumab.

Key Dates

Start date
May 8, 2019
Status verified
Feb 2025
Primary completion
Aug 1, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
522 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TACE/TAE Alone
    Transarterial Chemoembolisation (TACE) and/or Transarterial Embolisation (TAE) Alone.
  • Experimental: TACE/TAE and Nivolumab
    As above for TACE/TAE. Nivolumab adminstered as a flat dose of 480mg IV.

Primary Outcome Measure

Overall Survival - phase III primary outcome [ Time Frame: The time until death. Patients discontinuing the study, lost to follow-up or still alive at the end of the study will be censored at the last know date alive, this can be assessed up until 2 years after the last patient. ]

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