RecruitingPhase 2NCT04954781

TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Jul 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of TACE (a procedure that delivers chemotherapy directly into liver tumors while blocking their blood supply) with an immunotherapy drug called tislelizumab for people with advanced bile duct cancer (intrahepatic cholangiocarcinoma) that has not responded to at least one prior systemic treatment. **You may be eligible if...** - You are 18 or older - You have confirmed unresectable or metastatic intrahepatic bile duct cancer - You have already tried at least one line of systemic treatment (chemotherapy or targeted therapy) that did not work or caused unacceptable side effects - You have at least one measurable tumor - You have adequate blood count, liver, and kidney function - Your overall health allows for treatment (ECOG performance status 0–2) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have had a stroke, blood clot, or pulmonary embolism within the past 6 months - You have had major surgery, RFA, or resection within the past 4 weeks - You have previously received an anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapy drug - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have active hepatitis B and C co-infection, active tuberculosis, or HIV - You have a history of interstitial lung disease 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

DRUGTislelizumab

Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

COMBINATION_PRODUCTTACE

TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04954781


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