Actively Recruiting
Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma
Led by Chang Gung Memorial Hospital · Updated on 2023-09-13
120
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the clinical outcomes of Lenvatinib treatment alone or Lenvatinib + ADI-PEG20 combination treatment in advanced HCC patients with BCLC stage C.
CONDITIONS
Official Title
Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- Specific genotype status: rs-6025211 non-TT with rs9679162 non-GG genotype, or serum arginine level 65 84.2 BCM with rs9679162 non-GG genotype
- Treatment naive or on Lenvatinib treatment for less than 2 months
- Measurable disease with at least one measurable lesion using RECIST 1.1
- Child-Pugh score class A
- Barcelona Clinic Liver Cancer stage C
- ECOG performance status of 0 or 1 at enrollment
- Expected survival of at least 3 months
- Age over 18 years
- Fully recovered from prior surgery and none within 2 weeks prior to week 1 visit
- Use of appropriate contraception during the study for participants of childbearing potential
- Negative pregnancy test for females of childbearing potential before study entry
- Informed consent obtained
- No participation in concurrent investigational studies
- Total bilirubin less than 2.5 mg/dL with no bile obstruction
- ALT and AST less than or equal to 5 times upper limit of normal
- Serum albumin level 65 3.0 g/dl
- Prothrombin time less than 3 seconds above control or INR less than 1.7
- Absolute neutrophil count greater than 1,500/BCL
- Platelets greater than 50,000/BCL
- Serum uric acid less than or equal to 8 mg/dL
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance 65 40 mL/min if higher
- Stable treatment for active hepatitis B or C, except interferon
- Encephalopathy absent or mild (grade 1 or 2)
- Ascites absent or slight with diuretic therapy allowed
You will not qualify if you...
- Candidate for curative therapies or eligible for approved systemic therapies
- Prior allograft transplantation including liver transplantation
- Not fully recovered from toxicities of previous HCC treatments except Grade 1 alopecia
- Serious infection requiring systemic antibiotics currently or within 7 days before study treatment
- Pregnancy or lactation
- Expected non-compliance with study requirements
- Uncontrolled illnesses including active infections, severe heart failure, arrhythmia, psychiatric illness, or social situations limiting compliance
- History of other primary cancers except certain treated skin or cervical cancers or inactive tumors
- Prior treatment with ADI-PEG 20
- History of uncontrolled seizure disorder unrelated to cancer
- Known HIV positivity or active hepatitis B or C with AST or ALT over 5 times upper limit of normal
- Allergy to pegylated compounds or E. coli drug products
- Bleeding esophageal or gastric varices within 3 months unless treated
- Uncontrolled ascites not manageable with diuretics
- Recent blood transfusions or growth factor treatments within 7 days prior to screening or Week 1 visit
- Use of traditional medicines including Chinese herbs within 2 weeks prior to Week 1 visit
- ECOG performance status of 2 or higher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital, Linkou branch
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
W
Wei-Ting Chen, MD
CONTACT
T
Taiwan Linkou Chang Gung Memorial Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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