NCT06296563

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Lei ZHAO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	HAIC	FOLFOX-hepatic artery infusion for 2 times.
DRUG	Adebrelimab	Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most.
DRUG	Apatinib	Apatinib 250mg, po, qd,q3w,up to one year of use at most.

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2024-03-06
• Last updated: 2024-04-17

Locations

1 site across 1 country: China