HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC
- Conditions
- Hepatic Arterial Infusion ChemotherapyTyrosine Kinase InhibitorImmune Checkpoint InhibitorsHepatocellular Carcinoma (HCC)
- Interventions
- Procedure: hepatic artery infusion chemotherapyDrug: Immune Checkpoint Inhibitors
- Registration Number
- NCT06632106
- Lead Sponsor
- First Hospital of China Medical University
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 97
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
- Received at least 2 cycles of HAIC or ICIs treatments；
- Has repeated measurable intrahepatic lesions;
- Child-Pugh class A or B.
- Patients who took systemic anti-tumor treatments before the combination therapy;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HAIC plus TKIs and ICIs hepatic artery infusion chemotherapy Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks. HAIC plus TKIs and ICIs Tyrosine kinase inhibitor (TKIs) Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks. HAIC plus TKIs and ICIs Immune Checkpoint Inhibitors Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks. TKIs plus ICIs Tyrosine kinase inhibitor (TKIs) Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks. TKIs plus ICIs Immune Checkpoint Inhibitors Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.
- Primary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 2 years The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
- Secondary Outcome Measures
Name Time Method Progression free survival(PFS) Up to approximately 2 years The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST1.1) or death due to any cause, whichever occurs first.
Objective response rate(ORR) per RESCIST 1.1 Up to approximately 2 years The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
ORR of PVTT Up to approximately 2 years The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 Up to approximately 2 years The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Trial Locations
- Locations (1)
The first hospital of China medical university
🇨🇳Shenyang, Liaoning, China