Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint iInhibitors, real-world study
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.
Interventions
OTHERTACE+ICIs
TACE plus ICIs ( with or without molecular targeted therapies)
PROCEDURETACE
TACE without combination of ICIs ( with or without molecular targeted therapies)
Sponsors
Zhongda Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | up to approximately 2 years | The OS is defined as the time from the initiation of any combination treatment to death from any cause. |
| Time to Progression(TTP) | up to approximately 1 years | 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. |
| Objective response rate(ORR) | 6-8 week after TACE | The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST. |
| Disease control rate(DCR) | 6-8 week after TACE | The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST. |
| Adverse event(AE) | baseline to end of study (approximately 2 years) | Number and degree of the AEs according to CTCAE version 5.0. |
Countries
China
Outcome results
None listed