RecruitingPhase 2NCT06034977

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

Genotype Selected, Randomized, Open Label, Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma


Sponsor

Chang Gung Memorial Hospital

Enrollment

120 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining ADI-PEG 20 (a drug that starves cancer cells of a specific nutrient) with lenvatinib (a targeted therapy) can help patients with inoperable liver cancer (hepatocellular carcinoma) whose tumor has a specific genetic profile making it sensitive to this treatment. **You may be eligible if...** - You are 18 or older with confirmed liver cancer (hepatocellular carcinoma) - Your tumor has a specific genetic profile identified by testing (rs-6025211 or arginine levels) - You are either treatment-naive or have been on lenvatinib for less than 2 months - Your liver function is relatively preserved (Child-Pugh A) - You are in good physical condition (ECOG 0–1) - Your blood counts and liver/kidney function are within acceptable ranges **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are enrolled in another clinical trial - You have had surgery within the past 2 weeks - You have severely impaired liver or kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADI-PEG20

Lenvatinib + ADI-PEG20 combination treatment.


Locations(1)

Chang Gung Memorial Hospital, Linkou branch

Taoyuan, Taiwan

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NCT06034977


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