TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors (TIKET)

Tianjin Medical University

Status

Enrolling

Conditions

Hepatocellular Carcinoma Non-resectable

Liver Metastases

Cholangiocarcinoma Non-resectable

Liver Malignant Tumors

Treatments

Procedure: TACE with ICI

Study type

Interventional

Funder types

Other

Identifiers

NCT06487663

TCHIO-001

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.