Cholangiocarcinoma Non-resectable, Hepatocellular Carcinoma Non-resectable, Liver Malignant Tumors, Liver Metastases
Conditions
Keywords
Hepatocellular Carcinoma, Cholangiocarcinoma, Liver Metastases, Liver Malignant Tumors
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 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.
Interventions
PROCEDURETACE with ICI
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | Progression free survival |
| OS | 3 years | Overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 3 years | Objective response rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| TTP | 3 years | Time to Progression (TTP) as Determined by Investigator |
| DOR | 3 years | Duration of Responses (DOR) as Determined by Investigator |
| AE | Baseline up to approximately 48 months | Percentage of Participants With Adverse Events |
Countries
China
Contacts
Primary ContactHaipeng Yu
Outcome results
None listed