TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

Not Applicable

Recruiting

• Conditions: Liver Malignant Tumors; Hepatocellular Carcinoma Non-resectable; Liver Metastases; Cholangiocarcinoma Non-resectable
• Interventions: Procedure: TACE with ICI

• Registration Number: NCT06487663
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Study Timeline

• Study Start: 2020-10-27
• Status Verified: 2024-06
• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-10-27
• Study Completion: 2026-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
• Sign informed consent
• When screening for age, the age should be ≥ 18 years old
• Eligible for TACE treatment
• ECOG physical condition score is 0 or 1
• No prior systemic therapy for HCC, especially immunotherapy
• According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation

Exclusion Criteria

• Have any history of kidney disease or nephrotic syndrome
• Evidence of extrahepatic spread (EHS)
• Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
• Any condition representing a contraindication to TACE as determined by the investigators
• Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
• Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)
• Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)
• Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE combined ICI	TACE with ICI	TACE combined ICI

Primary Outcome Measures

Name	Time	Method
PFS	3 years	Progression free survival
OS	3 years	Overall Survival

Secondary Outcome Measures

Name	Time	Method
ORR	3 years	Objective response rate

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China