NCT06363825

A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

Single-arm, Prospective Clinical Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma With High Tumor Load

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load

Detailed description

At present, there are no prospective clinical studies using the combination regimen (TAE+HAIC+ Apatinib + camrelizumab) in the treatment of advanced liver cancer. Therefore, in this study, investigators designed a single-arm, prospective, multicenter, phase Ⅱ clinical study of arterial infusion of TAE+HAIC+ Apatinib + camrelizumab in the treatment of advanced liver cancer with high tumor load, to explore the safety and efficacy of this regimen. If study gets positive results, it will provide a reference for the subsequent phase Ⅲ clinical trial design, which is expected to provide a new effective approach for the treatment of advanced liver cancer.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	camrelizumab	TAE: 3-15ml iodized oil; HAIC: Indurating arterial catheter, oxaliplatin 85mg/m\^2 D1, arterial infusion, lasting 1-2 hours (d1), LV 400mg/m\^2, arterial infusion, lasting 2-3 hours (d1), 5-Fu 400mg/m\^2, arterial infusion, lasting 3 hours (d1), and fluorouracil 2400 mg/m\^2 for 24-48h; camrelizumab: 200mg, ivgtt, 30 min (not less than 20 min, not more than 60 min) every 3 weeks (21 days); apatinib mesylate: 250mg, once a day, taken orally (the time of daily administration should be as much as possible), with warm water.Stop for 3 days before next cycle intervention. Camrelizumab was given intravenously 1 day before TAE+HAIC treatment for each cycle, TAE+HAIC treatment was given on the second day, and oral apatinib was started after discharge.

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-04-11
• Completion: 2027-05-11
• First posted: 2024-04-12
• Last updated: 2024-04-17

Locations

1 site across 1 country: China