Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Zhongda Hospital
- Enrollment
- 826
- Locations
- 1
- Primary Endpoint
- Progression free survival(PFS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .
Detailed Description
Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.
Investigators
Gao-jun Teng
President
Zhongda Hospital
Eligibility Criteria
Inclusion Criteria
- •diagnosed with HCC by radiology, histology, or cytology;
- •patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
- •during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
- •patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.
Exclusion Criteria
- •exceeding the time interval of the combination therapy defined above;
- •missing follow-up data;
Outcomes
Primary Outcomes
Progression free survival(PFS)
Time Frame: up to approximately 1 years
The PFS is defined as the time from the initiation of any combination treatment to progression according to mRECIST or death from any cause. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
Secondary Outcomes
- Adverse event(AE)(baseline to end of study (approximately 2 years))
- Overall survival(OS)(up to approximately 2 years)
- Time to Progression(TTP)(up to approximately 1 years)
- Objective response rate(ORR)(6-8 week after TACE)
- Disease control rate(DCR)(6-8 week after TACE)