RecruitingPhase 2NCT06296563

Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

A Single Arm, Exploratory Clinical Study on the Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC


Sponsor

Lei ZHAO

Enrollment

20 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are: How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery. Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three treatments — adebrelimab (immunotherapy), apatinib (a targeted drug that cuts off blood supply to tumors), and HAIC (a procedure that delivers chemotherapy directly into the liver's blood vessels) — given before and after surgery for bile duct cancer (intrahepatic cholangiocarcinoma) that can be removed. **You may be eligible if...** - You have been diagnosed with bile duct cancer that starts inside the liver (intrahepatic cholangiocarcinoma) - Your cancer is at a stage where surgery may be possible (Stage Ib–IIIb) - You are 18 or older with good overall health and organ function - You have not received any prior cancer treatment (or had surgery for bile duct cancer at least 2 years ago with no recurrence) - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have previously received immunotherapy (PD-1/PD-L1 or CTLA-4 inhibitors) - You have serious uncontrolled conditions like high blood pressure, heart disease, or severe allergies - You have another active cancer - Your cancer cannot be surgically removed 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

PROCEDUREHAIC

FOLFOX-hepatic artery infusion for 2 times.

DRUGAdebrelimab

Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.

DRUGApatinib

Apatinib 250mg, po, qd,q3w,up to one year of use at most.


Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

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NCT06296563


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