RecruitingPhase 2NCT04834674

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

Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy


Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

20 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment for intrahepatic cholangiocarcinoma (ICC) — a cancer that starts in the bile ducts inside the liver — that has not responded to standard chemotherapy. The combination includes a liver-targeted procedure (DEB-TACE, which delivers chemotherapy beads directly into liver vessels), a targeted anti-cancer drug (apatinib), and an immune checkpoint inhibitor (a PD-1 blocker). **You may be eligible if...** - You have been diagnosed with intrahepatic bile duct cancer (ICC) - Your cancer stopped responding to first-line standard chemotherapy - Your cancer cannot be surgically removed and is not eligible for ablation or other curative treatments - You have at least one measurable tumor lesion - Your liver function is adequate (Child-Pugh score of 7 or below) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your cancer has spread extensively outside the liver in a way that makes liver-directed treatment unsafe - Your liver function is severely impaired - You have had recent significant bleeding or clotting problems - You have poor overall physical health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDEB-TACE combined with apatinib and PD-1 antibody

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


Locations(1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

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NCT04834674


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