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Hepatocellular CarcinomaPhase 2NCT06034977

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

A Phase 2 study testing ADI-PEG20 in people with Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
ADI-PEG20
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTaiwan
Study dates
1 Dec 2023to 23 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
  • Patients were rs-6025211 non-TT with rs9679162 non-GG genotype , or serum arginine level ≥ 84.2 µM with rs9679162 non-GG genotype. Treatment naïve or under Lenvatinib treatment for < 2 months.
  • Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present.
  • Child-Pugh (cirrhosis status) score class A (Appendix C).
  • Barcelona Cancer of the Liver (BCLC) stage C (Appendix B).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D).
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  • Expected survival of at least 3 months.
  • Age >18 years.
  • Fully recovered from prior surgery and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.
  • Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).
  • Informed consent must be obtained prior to study initiation.
  • No concurrent investigational studies are allowed.
  • Total bilirubin < 2.5 mg/dL and no evidence of bile obstruction.
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.
  • Serum albumin level ≥ 3.0 g/dl.
  • Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.7.
  • Absolute neutrophil count (ANC) >1,500/µL.
  • Platelets >50,000/µL.
  • Serum uric acid ≤ 8 mg/dL (with or without medication control).
  • Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.
  • Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.
  • Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.
  • Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed.

Who cannot join

  • Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.
  • Prior allograft transplantation including liver transplantation.
  • Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.
  • Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
  • Pregnancy or lactation.
  • Expected non-compliance.
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
  • Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.
  • Subjects who had been treated with ADI-PEG 20 previously.
  • History of uncontrolled seizure disorder not related to underlying cancer.
  • Known HIV positivity, or active hepatitis B infection, or active hepatitis C infection (AST or ALT > 5 x upper limit of normal).
  • Allergy to pegylated compounds.
  • Allergy to E. coli drug products (such as GMCSF).
  • Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
  • Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.
  • Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 2 weeks prior to week 1 visit.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Trial locations and contacts

1 site in 1 country.

Wei-Ting Chen, MD contact

886-3-3281200 ext. 8107

weiting1972@gmail.com

Taiwan Linkou Chang Gung Memorial Hospital contact

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital, Linkou branch

    Taoyuan, 333

    Wei-Ting Chen, MD

    Recruiting

Other trials in Taiwan

About this study

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

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

Being tested
ADI-PEG20
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADI-PEG20Drug

    Also called pegylated arginine deiminase

    Lenvatinib + ADI-PEG20 combination treatment.

Study groups in NCT06034977
Study groupRoleWhat they receive
LenvatinibPlacebo comparatorAdvanced HCC patients treated by Lenvatinib.
Receives: Drug: ADI-PEG20
Lenvatinib + ADI-PEG20ExperimentalAdvanced HCC patients treated by Lenvatinib + ADI-PEG20.
Receives: Drug: ADI-PEG20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival after the start of the intervention

    Measured: 2 years after the last enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion23 Jul 2026 (estimated)
  4. Study completion23 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034977
Sponsor's protocol ID
POLARIS 2023-LY-1
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADI-PEG20 in people with Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei-Ting Chen, MD (886-3-3281200 ext. 8107, weiting1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 2 years after the last enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06034977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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