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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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A randomized, open, multicenter clinical trial design was adopted, planned to be conducted in three stages, with 91 participants expected to be included in the study to evaluate the efficacy, tolerance, and safety of different doses of MB07133 in the treatment of unresectable advanced primary liver cancer.
first stage:The investigators plan to recruit 20 cases for mid dose group exploration: the injection MB07133600mg/m2/day group and the 1200mg/m2/day group, with 10 cases recruited for each group. The treatment cycle is 28 days, with each dose group receiving 7 days of medication and 21 days of rest per cycle.
second stage:Based on the data results of the first stage, the 1200mg/m2/day dose group MB07133 was selected for further expansion, with the same administration method as the first stage. Plan to recruit 30 subjects.
third stage:Based on the treatment results of H201110LC3, the 1800mg/m2/day dose group was selected for further expansion, and 40 subjects were recruited with the same administration method as the first stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB07133 600mg/m2/day | Experimental |
| |
| MB07133 1200mg/m2/day | Experimental |
| |
| MB07133 1800mg/m2/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB07133 | Drug | Evaluate the effectiveness and safety of different doses of MB07133 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time between the first medication and the occurrence (progression) or (death) of the tumor (for any reason). | Screening period, every 2 cycles after treatment(each cycle is 28 days)until the date of first documented progression or date of death from any cause(No more than 24 cycles are expected). |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time between the first medication use and (for any reason) death | Treatment period and follow-up period until the date of death from any cause(Up to 24 months after the last subject was enrolled). |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niu Junqi | Contact | 13910866712 | jianmingxu2014@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C497722 | 4-amino-1-(5-O-(2-oxo-4-(4-pyridyl)-1,3,2-dioxaphosphorinan-2-yl)arabinofuranosyl)-2(1H)-pyrimidinone |
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Adverse events occurring after treatment, as well as laboratory tests, vital signs, and electrocardiogram |
| From the beginning of medication to 35 days after the last administration |