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The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC-group | HAIC combined with ICIs and TKIs | ||
| TACE-group | TACE combined with ICIs and TKIs |
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| Measure | Description | Time Frame |
|---|---|---|
| alanine aminotransferase(ALT) | Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon |
| Measure | Description | Time Frame |
|---|---|---|
| The median progression free survival time (mPFS) | The progression free survival time defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 | From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Intermediate-to-Advanced HCC who received HAIC/TACE combined with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs
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| Name | Affiliation | Role |
|---|---|---|
| Jinzhang Chen | Nanfang Hospital, Southern Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
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| The median overall survival time (mOS) | Overall survival rate is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes early. | From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years) |
| Objective response rate (ORR) | From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years) |
| The disease control rate (DCR) | From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years) |