RecruitingNCT06643208

D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC

Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital


Sponsor

Fujian Provincial Hospital

Enrollment

37 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of liver-directed treatments (D-TACE plus HAIC — chemotherapy delivered directly into the liver's blood supply) together with two systemic drugs (envafolimab, an immunotherapy, and lenvatinib, a targeted therapy) for people with bile duct cancer inside the liver (intrahepatic cholangiocarcinoma, or ICC) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have unresectable ICC - Your liver function is reasonably preserved (Child-Pugh A or B) - Your cancer has at least one measurable area on imaging - You have not received prior cancer treatment - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have had prior organ transplant or are planning one - You have active autoimmune disease - You have an active serious infection - You have severe bleeding tendency or are on full-dose blood thinners - You are pregnant or breastfeeding - You have a history of another cancer in the past 5 years 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

DRUGTACE-HAIC, Envafolimab and Lenvatinib

TACE-HAIC (GEMOX regimen) combined with Envafolimab and Lenvatinib


Locations(1)

Fujian Provincial Hospital

Fuzhou, Fujian, China

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NCT06643208


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