RecruitingPhase 2NCT06298968

Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma

Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Prospective, Single-arm, Phase II Trial.


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

38 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a four-drug combination — gemcitabine, cisplatin (chemotherapy), lenvatinib (a targeted drug), and adebrelimab (an immunotherapy) — for people with advanced bile duct cancer starting inside the liver (intrahepatic cholangiocarcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 18–75 years old with a confirmed diagnosis of advanced, unresectable intrahepatic cholangiocarcinoma - You have good liver function (Child-Pugh A) and adequate organ function overall - You have at least one measurable tumor on scans - You have a life expectancy of at least 12 weeks - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have been previously treated with PD-1, PD-L1, or CTLA-4 immunotherapy - Your cancer includes liver cancer (hepatocellular carcinoma) or other non-bile duct tumor types - You have another active cancer - Your organ function does not meet the required minimums 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

DRUGcombined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab

Gemcitabine (1000mg/m²) and cisplatin (25mg/m²) on day1 and 8 every 3 weeks, with a total of 6 cycles. Lenvatinib 8 mg once daily (QD) oral dosing, continuous use for 2 years. Adebrelimab 1200mg intravenously every 3 weeks, continuous use for 2 years.


Locations(1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT06298968


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