RecruitingPhase 2NCT06208462

Neoadjuvant Therapy of HAIC(GEMOX) Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

Neoadjuvant Therapy of HAIC(GEMOX) Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors:NEO-ERA-01 Study


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

33 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Clinical Study on the efficacy and safety of HAIC(GEMOX)and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of treatments given before surgery for patients with intrahepatic cholangiocarcinoma (a type of bile duct cancer inside the liver) that has high-risk features for recurrence. The combination includes chemotherapy delivered directly into the liver's artery, an immunotherapy drug, and a targeted therapy called lenvatinib. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with resectable intrahepatic bile duct cancer with high-risk factors (such as large tumor, multiple tumors, vascular invasion, or lymph node involvement) - You have not received prior treatment for this cancer - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer is not surgically removable - You have previously received chemotherapy or immunotherapy for this cancer - You have serious liver, kidney, or heart problems 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

DRUGAdebrelimab

1200mg,i.v. , q3w

DRUGLenvatinib

8mg,qd

DRUGGemcitabine

800 mg/m2,q3w

DRUGOxaliplatin

85 mg/m2,q3w


Locations(3)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

West China Hospital

Chengdu, Sichuan, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06208462


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