Hepatocellular Carcinoma
Conditions
Interventions
Single Arm:Transarterial yttrium-90 resin microsphere internal radiation, followed by sintilimab treatment within 1 week
Sponsors
Shanghai Fourth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 75 years old; 2. ECOG PS score of 0-1, Child-Pugh class A-B7; 3. Confirmed diagnosis of hepatocellular carcinoma by histological examination or clinical diagnosis; 4. BCLC staging of B-C phase, with portal vein tumor thrombus (portal vein thrombus classification type I to II); 5. No extrahepatic metastasis, no ascites; 6. Tumor burden accounts for =50% of the liver volume; 7. Expected survival time greater than 3 months; 8. No prior treatment for HCC; 9. Inclusion of patients with HCC who are selected and deemed suitable for Yttrium-90 treatment and have passed Tc-MAA mapping.
Exclusion criteria
Exclusion criteria: 1. Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome, with a Child-Pugh classification of C; 2. Irreversible coagulopathy; 3. Renal dysfunction, with creatinine >176.8 µmol/L or creatinine clearance 2, cachexia, or multi-organ failure; 7. Abnormal hepatic arterial vascular anatomy, or the presence of severe, irreversible hepatic artery-portal vein shunts, hepatic artery-liver vein shunts; 8. Main portal vein tumor thrombus, thrombosis, with few collateral vessel formations, and inability to perform portal vein stenting to restore hepatic blood flow; 9. Irreversible hepatic artery-gastrointestinal artery shunt; 10. Severe iodinated contrast medium allergy; 11. Lung shunt fraction (LSF) exceeding the safety threshold (>20%), or a single pulmonary radiation dose exceeding 30 Gy, or a cumulative pulmonary radiation dose exceeding 50 Gy; 12. Other: including pregnant or lactating women and those deemed unsuitable for enrollment by the investigator, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Recurrence-Free Survival (RFS);Duration of Response (DoR);Surgical Conversion Rate;Major Pathologic Response ;Overall Survival ;Safety and Biomarkers; | — |
Countries
China
Contacts
Public ContactKai Lu
Shanghai Fourth People’s Hospital, Tongji University
Outcome results
None listed