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DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma

NCT04834674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-07

No results posted yet for this study

Summary

Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Surgical resection is currently the main method for the treatment of ICC. However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus cisplatin is the standard first-line incurable resection recommended in international and domestic guidelines. There is not a standard second-line treatment that has progressed after standard first-line chemotherapy.

The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and carrelizumab injection in the treatment of ICC that has progressed after standard first-line chemotherapy.

Patients who were aged 18 to 80 years with a histological or cytological diagnosis of ICC，locally advanced or multiple liver metastases, including progression after gemcitabine chemotherapy, will be enrolled in this trial.

Conditions

  • Intrahepatic Cholangiocarcinoma
  • Transarterial Chemoembolization
  • Apatinib
  • PD-1 Antibody

Interventions

COMBINATION_PRODUCT

DEB-TACE combined with apatinib and PD-1 antibody

combination of local therapy (DEB-TACE), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-04-05
Completion
2026-04-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04834674 on ClinicalTrials.gov