The Combination Therapy of TACE and Ablation With Durvalumab in Hepatocellular Carcinoma at Intermediate Stage (TAD)

Sponsor
Fudan University
Study ID
NCT04517227
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1 and is being developed by AstraZeneca/MedImmune for use in the treatment of cancer.
  • Transcatheter Hepatic Arterial Chemoembolization (TACE) — PROCEDURE
    TACE techniques have been described in the NCCN and ESMO-ESDO guidelines, including cTACE and DEB-TACE.
  • Ablation — PROCEDURE
    In this study, thermal ablation could be conducted with radiofrequency (RFA) or microwave (MWA).

Study Details

This is a pilot study with a single arm in a single center assessing safety and efficacy of combination therapy of TACE and ablation and durvalumab. This study will be conducted in selected patients with intermediate stage HCC not amenable to curative therapy.

Key Dates

Start date
Jul 31, 2021
Status verified
Apr 2021
Primary completion
Jun 30, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm
    All patients enrolled with receive the sequential therapy of TACE, ablation and durvalumab.

Primary Outcome Measure

Adverse events [ Time Frame: From date of the first treatment until 90 days after the last treatment, assessed up to 21 months ]

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