Actively Recruiting
A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma
Led by Asan Medical Center · Updated on 2026-03-18
33
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
A
Abbisko Therapeutics Co, Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2, open-label study to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Atezolizumab and Bevacizumab in patients with advanced or unresectable HCC harboring FGF19 overexpression. This study composes two parts, a Safety Run-in part to evaluate safety and establish the dose of Irpagratinib for the triple combination, and an Expansion part to evaluate the preliminary efficacy and safety using Simon's two-stage design.
CONDITIONS
Official Title
A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent and be able to follow study visits and procedures.
- Male or female patients aged 19 years or older.
- Histological or cytological confirmation of advanced or unresectable hepatocellular carcinoma not suitable for curative surgery or local therapies.
- Positive test for FGF19 overexpression from archived liver primary lesion tissue.
- Barcelona Clinic Liver Cancer (BCLC) stage B or C and Child-Pugh score 5 to 6 without hepatic encephalopathy or clinically apparent ascites requiring intervention.
- At least one target lesion measurable by RECIST v1.1.
- ECOG performance status of 0 or 1.
- Life expectancy of 3 months or more.
- Adequate organ and blood function based on specified laboratory values within 14 days before first treatment.
- Patients of childbearing potential must agree to use effective birth control during the study and for 6 months after, females must have a negative pregnancy test and not be breastfeeding.
You will not qualify if you...
- Prior systemic chemotherapy or investigational anticancer agents for advanced/unresectable HCC, except one cycle of Atezolizumab plus Bevacizumab.
- Previous treatment with immune checkpoint inhibitors or immune stimulatory agents, except one cycle of Atezolizumab plus Bevacizumab.
- Previous treatment with FGFR inhibitors.
- Locoregional liver therapy within 4 weeks before first dose.
- Major surgery, radiotherapy, or loco-regional treatment within specific timeframes before treatment.
- Unresolved toxicities from prior therapies greater than Grade 1 (with some exceptions).
- Use of certain medications like P-gp inhibitors, CYP3A4 modulators, systemic corticosteroids, or immunosuppressants within specified periods.
- Vaccination with live attenuated vaccines within 4 weeks before treatment.
- Chronic daily use of NSAIDs.
- Active infection or unexplained fever above 38.5°C or recent antibiotic treatment.
- Known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma.
- Active CNS metastasis or metastatic disease involving major airways or vessels.
- Uncontrolled fluid accumulations requiring intervention or history of hepatic encephalopathy.
- Liver tumor occupying 50% or more of the liver.
- Certain portal vein tumor thrombus types.
- Untreated or high-risk esophageal/gastric varices.
- Recent biopsy or minor surgery within 3 days before Bevacizumab.
- Recent history of fistula, GI perforation, or intra-abdominal abscess.
- Recent second primary malignancy, severe allergies, autoimmune diseases (with exceptions), significant ECG abnormalities, impaired heart function, or serious infections.
- Immunodeficiency, active HBV or HCV infection without adequate management.
- Other significant comorbidities or conditions compromising safety or compliance.
- History of stem cell or organ transplantation.
- Recent bleeding events, coagulopathy, or use of certain anticoagulants.
- Serious wounds, ulcers, fractures, or inability to take oral medication adequately.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center,
Seoul, South Korea
Actively Recruiting
Research Team
C
Changhoon Yoo
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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