RecruitingPhase 2NCT06925516

A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC

Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Regimen Chemotherapy as the First-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (ICC): A Single-arm, Multicenter, Phase II Study


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

38 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — apatinib (an anti-angiogenic drug that cuts off blood supply to tumours), adebrelimab (an immunotherapy drug), and chemotherapy — in patients with intrahepatic cholangiocarcinoma (a type of bile duct cancer that starts inside the liver) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have biopsy-confirmed intrahepatic cholangiocarcinoma (ICC) that cannot be removed by surgery or has come back after surgery - You have not had any prior systemic (whole-body) treatment for advanced ICC (except chemotherapy more than 6 months after a curative surgery) - Any prior local treatments (e.g., radiation, ablation) were completed at least 4 weeks ago **You may NOT be eligible if...** - Your cancer has already been treated with systemic therapy - You have severe liver or organ failure - You are pregnant or breastfeeding 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

DRUGApatinib and Adebrelimab in Combination With chemotherapy

Patients would receive Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles. Apatinib and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.


Locations(1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT06925516


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