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Compares treatment options for Hepatocellular Carcinoma
Official title Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05317819
What this study is testing
What is ADI-PEG20?
ADI-PEG20 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as pegargiminase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
- Prior treatment with at least 1 systemic agent for Child-Pugh A people. However, Child-Pugh B7 people without prior systemic treatment may be...
- Plasma arginine ≥ 78 μM at pre-screening visit.
- Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. people who have received local-regional therapies are...
- Child-Pugh (cirrhosis status) score class A-B7 (Appendix C).
You likely can't join if
- Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling...
- Prior allograft transplantation including liver transplantation.
- people 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 intravenous, systemically administered antibiotics at the time of study entrance, or an infection...
- Pregnancy or lactation.
- Expected non-compliance.
See the full eligibility criteria
- Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
- Prior treatment with at least 1 systemic agent for Child-Pugh A people. However, Child-Pugh B7 people without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies (e.g...
- Plasma arginine ≥ 78 μM at pre-screening visit.
- Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. people who have received local-regional therapies are eligible, provided that they have either a target lesion which has...
- Child-Pugh (cirrhosis status) score class A-B7 (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).
- Expected survival of at least 3 months.
- Age \>18 years.
- Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.
- Female people and male people must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20/placebo. Male partners of female...
- Informed consent must be obtained prior to study initiation.
- No concurrent investigational studies are allowed.
- Total bilirubin \< 3.0 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.
- people 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.
- 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.
- people 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 intravenous, 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...
- Pregnancy or lactation.
- Expected non-compliance.
- 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...
- people 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)...
- people who had been treated with ADI-PEG 20 previously.
- History of uncontrolled seizure disorder not related to underlying cancer.
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
The study team makes the final eligibility decision.
Where it's taking place
- Changhua, Taiwan
- Chiayi City, Taiwan
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taoyuan, Taiwan
- Hanoi, Vietnam
- Hà Nội, Vietnam
- Huế, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changhua, Taiwan; Chiayi City, Taiwan; Kaohsiung City, Taiwan; Tainan, Taiwan; Taoyuan, Taiwan; Hanoi, Vietnam and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.