OncoMatch/Clinical Trials/NCT07010497
A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma
Is NCT07010497 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies irpagratinib for carcinoma, hepatocellular.
Treatment: irpagratinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: FGF19 overexpression (positive as defined)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: Patient who has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.
Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC. Patient who has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.
Cannot have received: immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-TIGIT, OX-40, CD137)
Exception: Patients has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.
Has received prior therapy with immune checkpoint inhibitors or immune stimulatory agents (eg, anti-PD-1, anti-PD-L1/2, anti-CTLA-4, anti-TIGIT, OX-40, or CD137). Patients has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.
Cannot have received: FGFR inhibitor (selective FGFR4 inhibitor, pan-FGFR inhibitor)
Previous treatment with FGFR inhibitors including selective FGFR4 or pan-FGFR inhibitors.
Cannot have received: locoregional therapy (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization, ablation)
Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study intervention.
Cannot have received: major surgery
Exception: except palliative therapy
Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure >30%), loco-regional treatment <4 weeks; endocrine therapy with anti-tumor indications for < 2 weeks.
Cannot have received: radiotherapy
Exception: bone-marrow exposure >30%
radiotherapy (bone-marrow exposure >30%)
Cannot have received: endocrine therapy with anti-tumor indications
endocrine therapy with anti-tumor indications for < 2 weeks
Lab requirements
Blood counts
ANC ≥1.0×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin ≥85g/L (8.5g/dL)
Kidney function
Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL/min based on Cockcroft-Gault formula
Liver function
Total bilirubin (TBIL) ≤3×ULN; AST and ALT ≤ 5 ×ULN; Child-Pugh score 5~6 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention
Cardiac function
Left ventricle ejection fraction ≥50%; No QTcF > 470 ms; No NYHA class III or IV CHF, unstable angina, MI within 6 months, arrhythmia requiring treatment, or uncontrolled hypertension (SBP≥150mmHg and/or DBP≥100mmHg)
Adequate organ and hematologic function as indicated by the following screening assessments...; QTcF > 470 ms [excluded]; Left ventricle ejection fraction<50% [excluded]; Impaired cardiac function or clinically significant cardiac disease [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify