NCT06487663

TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.

Detailed description

The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle. Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Cholangiocarcinoma Non-resectable
• Liver Metastases
• Liver Malignant Tumors

Interventions

Type	Name	Description
PROCEDURE	TACE with ICI	Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

Timeline

• Start date: 2020-10-27
• Primary completion: 2025-10-27
• Completion: 2026-10-27
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: China