TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
NCT ID: NCT06487663
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-10-27
2026-10-27
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TACE combined ICI
TACE combined ICI
TACE with ICI
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Interventions
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TACE with ICI
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Haipeng Yu
Professor
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TCHIO-001
Identifier Type: -
Identifier Source: org_study_id
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