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This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.
Data of Patients who have received Triplet therapy ( transarterial therapies+donafenib+Anti-PD-1 Antibody）will be collected，excluding incomplete data.
The primary endpoint was the objective response rate (ORR)，Secondary endpoints included disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS)， as well as adverse event.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transarterial therapies | Procedure | transarterial therapies combine with donafenib and Anti-PD-1 Antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| the objective response rate (ORR) | ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST | From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST | From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months) |
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Inclusion Criteria:
7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Exclusion Criteria:
1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data.
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Patients with Unresectable Hepatocellular Carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxin Pan, Prof. | Contact | 18928918216 | 18928918216 | pmxwxy@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingxin Pan, Prof. | Southern Medical University, China | Principal Investigator |
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| ID | Term |
|---|---|
| C000710249 | donafenib |
| C000711728 | spartalizumab |
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| The progression-free survival rate (PFSR) | PFSR is defined as the percentage of participants who have not accured disease progression or death at the time of 6 or 12 months as assessed by RECIST 1.1 and mRECIST | From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months) |
| The overall survival rate (OSR) | OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months. | From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months) |
| The progression-free survival time (mPFS) | The progression-free survival time (mPFS) defined as the time from begining triplet therapy to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST | From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months) |
| The median overall survival time (mOS) | OS is measured from the start date of the Treatment (date of begining triplet therapy) 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 earlier. | From the start date of the Treatment until date of death from any cause (max 24 months) |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the begining triplet therapy until date of death from any cause (max 24 months) |