Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

Zhongda Hospital826 enrolled

Overview

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) .

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.

Study Type

OBSERVATIONAL

Enrollment

826

Conditions

Hepatocellular Carcinoma

Interventions

TACE+ICIsOTHER

TACE plus ICIs ( with or without molecular targeted therapies)

TACEPROCEDURE

TACE without combination of ICIs ( with or without molecular targeted therapies)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. diagnosed with HCC by radiology, histology, or cytology; 2. 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; 3. 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; 4. 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: 1. exceeding the time interval of the combination therapy defined above; 2. missing follow-up data;

Locations (1)

Gao-Jun Teng

Nanjing, China

Outcomes

Primary Outcomes

Progression free survival(PFS)

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).

Time frame: up to approximately 1 years

Secondary Outcomes

Overall survival(OS)

The OS is defined as the time from the initiation of any combination treatment to death from any cause.

Time frame: up to approximately 2 years

Time to Progression(TTP)

The TTP is defined as the time from the initiation of any combination treatment to progression according to mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm.

Time frame: up to approximately 1 years

Objective response rate(ORR)

The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST.

Time frame: 6-8 week after TACE

Disease control rate(DCR)

The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST.

Time frame: 6-8 week after TACE

Adverse event(AE)

Number and degree of the AEs according to CTCAE version 5.0.

Time frame: baseline to end of study (approximately 2 years)

Data from ClinicalTrials.gov

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