RecruitingNot ApplicableNCT06487663

TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

40 participants

Start Date

Oct 27, 2020

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria8

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.

Interventions

PROCEDURETACE with ICI

Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors

Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

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NCT06487663

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