RECRUITINGINTERVENTIONAL
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
About This Trial
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.
Who May Be Eligible (Plain English)
Who May Qualify:
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Sign willing to sign a consent form
- When screening for age, the age should be ≥ 18 years old
- Eligible for TACE treatment
- ECOG physical condition score is 0 or 1
- No previous cancer treatment that works throughout the body (like chemotherapy) for HCC, especially immunotherapy
- According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
PROCEDURE
TACE with ICI
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China