Actively Recruiting
Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma
Led by Yoon Jun Kim · Updated on 2025-05-14
24
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
Y
Yoon Jun Kim
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma
CONDITIONS
Official Title
Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and comply with study requirements
- Male or female aged 19 years or older
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by histology or imaging
- Barcelona clinic liver cancer (BCLC) stage B or C with or without limited extrahepatic disease
- At least one untreated measurable tumor lesion
- Child-Pugh class A liver function (score 5 or 6)
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Body weight greater than 30 kg
- Adequate organ and marrow function including hemoglobin ≥9.0 g/dL, ANC ≥1500/mm3, platelets ≥75,000/mm3, albumin ≥2.8 g/dL, bilirubin ≤1.5 times institutional upper limit (exceptions for Gilbert's syndrome), AST/ALT ≤5 times institutional upper limit, and creatinine clearance >40 mL/min
- Female participants must be postmenopausal or have a negative pregnancy test and agree to use two forms of contraception if sexually active
- Male participants must be surgically sterile or use acceptable contraception if sexually active with a premenopausal partner
- Willing and able to comply with the study protocol including treatments and visits
You will not qualify if you...
- Eligible for potentially curative treatments such as surgery, radiofrequency ablation, or immediate liver transplantation
- Prior treatment with immune checkpoint inhibitors or drugs targeting T-cell co-stimulation or immune pathways
- History of organ or stem cell transplantation
- Other active cancers except certain treated skin, cervical, thyroid, or gastric cancers with at least 5 years disease-free
- Severe allergy to contrast agents not controlled by premedication
- Any condition interfering with evaluation or safety of the investigational product
- Participation in another interventional clinical trial within the last 8 weeks or 5 half-lives of the study drug
- Recent anticancer therapy within 1 cycle length or 14 days prior to study drug
- Unresolved significant toxicity from prior treatments except alopecia, vitiligo, and specified lab abnormalities
- Concurrent chemotherapy, investigational, biologic, or hormonal cancer treatments (non-cancer hormonal therapies allowed)
- Prior hepatic radiation therapy
- Major surgery within 28 days before first study drug dose (palliative local surgery allowed)
- Active or prior autoimmune or inflammatory disorders except specified exceptions
- Uncontrolled intercurrent illness including infections, heart failure, unstable angina, arrhythmia, lung disease, serious gastrointestinal or psychiatric conditions
- History of leptomeningeal carcinomatosis
- Active primary immunodeficiency or HIV positive
- Active infections including tuberculosis (except controlled chronic HBV or HCV infections as specified)
- Use of immunosuppressive medication within 14 days before first study drug dose except specified exceptions
- Receipt of live vaccines within 30 days prior to first study drug dose
- Pregnant or breastfeeding women or those unwilling to use effective contraception during and after the study
- Known allergy to study drugs or their components
- Investigator judgment deeming patient unsuitable or unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
Y
Yoon Jun Kim, MD, PhD
CONTACT
Y
Yun Bin Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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