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This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLM60 | Experimental | Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome-entrapped Mitoxantrone Hydrochloride Injection | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limited toxicity (DLT) | To identify the dose-limited toxicity (DLT). | 1year |
| Maximum tolerated dose (MTD) | To identify the maximum tolerated dose (MTD). | 1 year |
| Recommended Phase II Dose (RP2D) | To identify the Recommended Phase II Dose (RP2D) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | To preliminarily evaluate the AUC in patients with advanced HCC. | 2 years |
| Peak Plasma Concentration (Cmax) | To preliminarily evaluate Cmax in patients with advanced HCC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Lou | Contact | 0311-67808817 | loukun@mail.ecspc.com | |
| Xuefang Xia | Contact | 010-63930702 | xiaxuefang@mail.ecspc.com |
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| 2 years |
| Time of peak plasma concentration (Tmax) | To preliminarily evaluate Tmax in patients with advanced HCC. | 2 years |
| Median overall survival (OS) | To preliminarily evaluate ORR in patients with advanced HCC. | 2 years |
| Median progression free survival (PFS) | To preliminarily evaluate PFS in patients with advanced HCC. | 2 years |
| Overall response rate (ORR) | To preliminarily evaluate ORR in patients with advanced HCC. | 2 years |
| Duration of Response (DoR) | To preliminarily evaluate DoR in patients with advanced HCC. | 2 years |