Yttrium-90 selective internal radiotherapy plus sequential hepatic arterial infusion chemotherapy for Yttrium-90 selective internal radiotherapy plus sequential hepatic arterial infusion chemotherapy for unresectable intrahepatic cholangiocarcinoma: A prospective, single-arm phase II trial: A prospective, single-arm phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500100518

Enrollment

Unknown

Registered

2025-04-10

Start date

2025-04-15

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable liver-confined ICCA

Interventions

Test group:90-SIRT sequential hepatic arterial infusion chemotherapy

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 =1; 7. Tumor extent =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 =3× ULN, serum creatinine <=1.5× ULN, prothrombin time (PT) prolongation <4 seconds; 10. Life expectancy of at least 3 months; 11. Age range from 18 to 75 years old, both male and female are acceptable.

Exclusion criteria

Exclusion criteria: 1. Bile duct or portal vein invasion beyond unilateral involvement (contralateral or main trunk infiltration); 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. 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);Adverse Events (AEs);Progression free survival (PFS);	—

Countries

China

Contacts

Public ContactZhu Kangshun

Second Affiliated Hospital of Guangzhou Medical University

zhksh010@163.com+86 20 34156205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026