Gao-Jun Teng
Nanjing, China
NCT Number: NCT04975932
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) .
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Notify Me18 year and older
All sexes
Observational
Nanjing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TACE plus ICIs ( with or without molecular targeted therapies)
TACE without combination of ICIs ( with or without molecular targeted therapies)
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).
Time frame: 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 frame: 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.
Time frame: 6-8 week after TACE
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
The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST.
Time frame: baseline to end of study (approximately 2 years)
Number and degree of the AEs according to CTCAE version 5.0.
Zhongda Hospital
Other
Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study
Acronym: CHANCE001
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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