Clinical trial NCT06487663: TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
Official title: Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Cholangiocarcinoma Non-resectable
Liver Metastases
Liver Malignant Tumors
Keywords: Hepatocellular Carcinoma
Cholangiocarcinoma
Liver Metastases
Liver Malignant Tumors
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PFS
timeFrame: 3 years
measure: OS
timeFrame: 3 years
Secondary outcomes:
measure: ORR
timeFrame: 3 years
Other outcomes:
measure: TTP
timeFrame: 3 years
measure: DOR
timeFrame: 3 years
measure: AE
timeFrame: Baseline up to approximately 48 months
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
References: