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Trial Title:
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
NCT ID:
NCT06487663
Condition:
Hepatocellular Carcinoma Non-resectable
Cholangiocarcinoma Non-resectable
Liver Metastases
Liver Malignant Tumors
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Carcinoma, Hepatocellular
Cholangiocarcinoma
Liver Neoplasms
Conditions: Keywords:
Hepatocellular Carcinoma
Cholangiocarcinoma
Liver Metastases
Liver Malignant Tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TACE with ICI
Description:
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Arm group label:
TACE combined ICI
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 catheter is retained in the hepatic artery or left or right hepatic
artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J
Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for
more than 4 hours on the first day. After HAIC is completed, remove the catheter and
sheath. Repeat catheterization in the next treatment cycle.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zheng
Phone:
0086-22-23340123
Email:
info@tjmuch.com
Investigator:
Last name:
Haipeng Yu, PhD
Email:
Principal Investigator
Start date:
October 27, 2020
Completion date:
October 27, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487663
