NCT06239532

HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.

Detailed description

Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time； Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	HAIC+TAE	Procedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ，continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days.
DRUG	Tislelizumab	Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
DRUG	Surufatinib	Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-02-02
• Last updated: 2024-11-21

Locations

1 site across 1 country: China