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Clinical Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Systemic Therapy in Patients with Unresectable Intrahepatic Cholangiocarcinoma Refractory to First-Line Treatment

Clinical Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Systemic Therapy in Patients with Unresectable Intrahepatic Cholangiocarcinoma Refractory to First-Line Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115791
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

Hepatic Arterial Infusion Chemotherapy (HAIC):None

Sponsors

The second affiliated hospital of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (ICC); 2.Age >= 18 years; 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Documented failure of first-line standard systemic chemotherapy, followed by second-line treatment with HAIC combined with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy). First-line standard chemotherapy was defined as a gemcitabine plus platinum-based doublet regimen. *Failure of first-line therapy was defined as: disease progression during treatment or within 6 months after the last dose or discontinuation due to intolerable toxicity; 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of histologically or cytologically confirmed components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma (other than the specified intrahepatic cholangiocarcinoma under study); 2.Patients with missing baseline data or unavailable survival status; 3.Women who are pregnant or lactating; 4.Patients with significant arteriovenous shunting; 5.Contraindications to interventional therapy, such as:Severe hepatic cirrhosis/Moderate to large amounts of ascites/Child-Pugh class C liver function 6.Severe dysfunction of vital organs (e.g., heart, brain, lungs); 7.Uncontrolled conditions including hypertension, gastrointestinal bleeding, or coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall Survival;Treatment-related adverse events;Changes in tumor markers;

Countries

China

Contacts

Public ContactYe Mao

The second affiliated hospital of nanchang university

rayooocat111@163.com+86 136 8403 5878

Outcome results

None listed

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