Unresectable liver-confined ICCA
Conditions
Interventions
SIRT+LEN_SIN:SIRT plus lenvatinib and sintilimab
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Confirmed diagnosis of intrahepatic cholangiocarcinoma (ICCA); 2.Tumor confined to the liver and deemed unresectable; 3.Recurrent tumors after prior surgical resection or ablation are eligible; 4.At least one measurable intrahepatic target lesion; 5.Child-Pugh class A or B liver function; 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score =75×10?/L, white blood cell count >3.0×10?/L, absolute neutrophil count >1.5×10?/L, hemoglobin >=85 g/L, ALT/AST =28 g/L, total bilirubin =100 IU/mL. Patients with chronic hepatitis C (HCV) infection are eligible but must have completed anti-HCV treatment before enrollment; 11.Life expectancy of at least 3 months; 12. Both male and female; 13. Age 18~75 years old;
Exclusion criteria
Exclusion criteria: 1.Bile duct or portal vein invasion beyond unilateral involvement (contralateral or main trunk involvement); 2.Inferior vena cava tumor thrombus; 3.Extrahepatic metastasis; 4.Prior liver-directed therapies (e.g., transarterial chemoembolization, hepatic arterial infusion chemotherapy, radiotherapy) or systemic therapy; 5.History of organ or stem cell transplantation; 6.History of other malignancies; 7.History of esophageal/gastric variceal bleeding; 8.History of hepatic encephalopathy; 9.Organ (heart, lung, kidney) insufficiency making SIRT intolerable; 10.HIV infection; 11.Co-infection with hepatitis B and hepatitis C virus; 12.Autoimmune disease; 13.Requirement for long-term systemic corticosteroid therapy (daily dose equivalent to >10 mg prednisone) or any form of immunosuppressive therapy; 14.Pregnancy, lactation, or intention to conceive;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Overall survival (OS);Progression free survival (PFS);Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactZhu Kangshun
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed