Status:
RECRUITING
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Hepatocellular Carcinoma Non-resectable
Cholangiocarcinoma Non-resectable
Eligibility:
All Genders
18-75 years
Phase:
NA
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 cathet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 27 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06487663
Start Date
October 27 2020
End Date
October 27 2026
Last Update
July 5 2024
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China