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

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT04834674
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Apr 2026
Primary completion
Apr 5, 2026
Completion
Apr 5, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DEB-TACE combined with apatinib and PD-1 antibody
    The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: Change from baseline tumor volume at 6 months ]

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