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Clinical study for embolization of intrahepatic cholangiocarcinoma with irinotecan loaded with polyvinyl alcohol embolic microspheres

A single-center randomized controlled study for intrahepatic cholangiocarcinoma using DEB-TACE-loaded irinotecan and C-TACE combined with irinotecan infusion chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022856
Enrollment
Unknown
Registered
2019-04-28
Start date
2019-05-20
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

Intrahepatic cholangiocarcinoma

Interventions

DEB-TACE:Irinotecan loaded on drug-loaded microspheres
C-TACE:Lipiodol embolization combined with irinotecan infusion chemotherapy

Sponsors

Intervention Department, Fifth Medical Center, General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria, age 18-75, both men and women can be enrolled in the group; ? TNM stage was stage II and III, and at least one lesion could be measured; ? Child-Pugh A/B grade (= 9 points); ? Physical fitness score (ECOG score) of Eastern Cancer Collaboration Group = 2; ? TBIL =3 mg/L, ALT/AST =5 times the upper limit of normal value, prothrombin activity = 40%, renal function =1.5 times normal value, blood routine neutrophil absolute value =1.5 x 10^9/L, HGB =90 g/L, and the expected survival time is at least 6 weeks; ? Signing consent before treatment.

Exclusion criteria

Exclusion criteria: ? Participation in other clinical trials/drug trials within 3 months before admission; ? Massive ascites or severe jaundice; ? Extremely ill or cachexia; ? Severe multiple organ dysfunction; ? Active infections, especially those associated with biliary tract infections; ? Previous patients receiving embolic liver radiotherapy and other ablative therapies; ? Upper gastrointestinal bleeding occurred one month before the portal vein trunk was completely blocked with a liver tumor load greater than 70%; ? Human immunodeficiency virus (HIV) infection.

Design outcomes

Primary

MeasureTime frame
Five year survival rate;

Secondary

MeasureTime frame
Progression free survival;local control rate;complete remission rate;

Countries

China

Contacts

Public ContactHui Xie

Fifth Medical Center of PLA General Hospital

xh302jr@126.com+86 13391507655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026