Unresectable liver-confined ICCA
Conditions
Interventions
(SIRT+HAIC+LEN+SIN):SIRT+HAIC+LEN+SIN
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years old; 2. Male and female; 3. Diagnosis of intrahepatic cholangiocarcinoma; 4. The tumor was confined to the liver and inoperable; 5. Patients with recurrent tumors after surgical resection or ablation were eligible. 6. At least one measurable intrahepatic target lesion; 7. Liver function Child-Pugh A/B; 8. Eastern Cooperative Oncology Group performance status (ECOG PS) =75×10^9/L, white blood cell count > 3.0×10^9/L, absolute neutrophil count > 1.5×10^9/L, hemoglobin >=85 g/L, alanine aminotransferase and alanine aminotransferase AST=28g/L, total bilirubin 3 months.
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/HAIC 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 |
|---|---|
| Progression free survival (PFS);Disease control rate (DCR);Adverse Events (AEs);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZhu Kangshun
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed