OncoMatch/Clinical Trials/NCT03899428
Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC
Is NCT03899428 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for hepatocellular carcinoma.
Treatment: Durvalumab · Sorafenib · Lenvatinib · Regorafenib · Cabozantinib — It is estimated that over 50% of HCC cases worldwide are related to chronic HBV. There are approximately 350-400 million people across the world infected with HBV, the majority reside in or originate from Asia. Each year HBV accounts for 749,000 new cases of HCC and 692,000 HCC-related deaths. The annual incidence of HCC is estimated to be \<1% for non-cirrhotic HBV infected patients and 2-3% for those with cirrhosis. While the most approved nucleos(t)ide analogues (NA) suppress HBV replication through inhibition of HBV-DNA polymerase and are reported to reduce the risk of HCC incidence, however, such risk is not completely eliminated under NA treatment. The recent availability of commercial quantitative assays of serum hepatitis B surface antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or entecavir therapy is slower and less pronounced compared to interferon treatment, despite a higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that the predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is more than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear advantage in reducing the treatment duration required to achieve HBsAg-loss. Interestingly, in a recent preliminary study, 12-weeks of treatment with nivolumab has showed the modest effect on HBsAg decline in HBeAg negative CHB patients. Thus, in this clinical trial, the investigator will investigate whether immune checkpoint therapy is more effective in inducing HBsAg decline compared with target therapy in HBsAg-positive patients with advanced stage HCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE B (THAT IS NOT ELIGIBLE FOR LOCOREGIONAL THERAPY), BCLC STAGE C (BCLC)
Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: nucleoside analog reverse transcriptase inhibitor (entecavir, tenofovir, TAF) — before initiation of anti-PDL1 or TKI
Treated with either entecavir or tenofovir or TAF before initiation of anti-PDL1 or TKI
Cannot have received: interferon
Prior interferon treatment
Cannot have received: radiation therapy
Exception: radiation for bone metastases within 2 weeks; other radiation within 4 weeks; radionuclide treatment (e.g., I-131 or Y-90) within 6 weeks
Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 6 weeks of starting treatment
Lab requirements
Blood counts
Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1000/μL; Platelet count ≥75000/μL; INR ≤1.6
Kidney function
Calculated creatinine clearance ≥50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
Liver function
Total bilirubin (TBL) ≤2.0× ULN; AST and ALT ≤5×ULN; Albumin ≥2.8 g/dL; Child-Pugh Score class A or B
Adequate organ and marrow function, as defined below. Criteria "a," "b," "c," and "f" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose. Hemoglobin ≥9 g/dL Absolute neutrophil count ≥1000/μL Platelet count ≥75000/μL Total bilirubin (TBL) ≤2.0× ULN AST and ALT ≤5×ULN Albumin ≥2.8 g/dL INR ≤1.6 Calculated creatinine clearance ≥50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance QTcF ≤ 500 ms within 7 days before starting treatment (if >500 ms, average of 3 ECGs must be ≤500 ms) Child-Pugh Score class A or B
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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