TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
TIKET
Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
1 other identifier
interventional
40
1 country
1
Brief Summary
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2026
ExpectedJuly 5, 2024
June 1, 2024
5 years
June 9, 2024
June 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PFS
Progression free survival
3 years
OS
Overall Survival
3 years
Secondary Outcomes (1)
ORR
3 years
Other Outcomes (3)
TTP
3 years
DOR
3 years
AE
Baseline up to approximately 48 months
Study Arms (1)
TACE combined ICI
EXPERIMENTALTACE combined ICI
Interventions
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 9, 2024
First Posted
July 5, 2024
Study Start
October 27, 2020
Primary Completion
October 27, 2025
Study Completion (Estimated)
October 27, 2026
Last Updated
July 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share