Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT06034977
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ADI-PEG20 — DRUG
    Lenvatinib + ADI-PEG20 combination treatment.

Study Details

To compare the clinical outcomes of Lenvatinib treatment alone or Lenvatinib + ADI-PEG20 combination treatment in advanced HCC patients with BCLC stage C.

Key Dates

Start date
Dec 1, 2023
Status verified
Sep 2023
Primary completion
Jul 23, 2026
Completion
Jul 23, 2026

Study Design

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

Arms

  • Placebo Comparator: Lenvatinib
    Advanced HCC patients treated by Lenvatinib.
  • Experimental: Lenvatinib + ADI-PEG20
    Advanced HCC patients treated by Lenvatinib + ADI-PEG20.

Primary Outcome Measure

Overall survival [ Time Frame: 2 years after the last enrollment ]

Central Contacts

  • Wei-Ting Chen, MD
    886-3-3281200
    [email protected]
  • Taiwan Linkou Chang Gung Memorial Hospital

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