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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion,in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB07133+Sintilimab | Experimental | The test is divided into 2 stages: fist stage is dose escalation:Sintilimab 200mg,MB07133 injection is divided into three dosage groups: 600mg/m2/day, 1200mg/m2/day, and 1800mg/m2/day. second stage Dose expansion:Sintilimab 200mg+MB07133 1800mg/m2/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab 200mg+MB07133 600mg | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with DLT Event | According to the internationally recognized NCI-CTCAE 5.0 toxicity evaluation standard | From initial administration to 21 days after starting administration |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | All adverse medical events that occur after subjects receive the investigational product can be manifested as symptoms, signs, diseases, or laboratory abnormalities, but do not necessarily have a causal relationship with the investigational product. | Starting to receive the experimental drug until 24 days after the last application |
| PFS | The time between the start of medication and the occurrence of objective tumor progression or death(RECIST1.1 ) | Screening period, every 2 cycles after starting treatment(each cycle is 21 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 |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of Sintilimab | Pharmacokinetics of Sintilimab | Within 0.5 hours before infusion,0.5hour (± 5 min) after the start of infusion,4hour(±5min)、10hour(±5min)、25hour(±30min)、73hour(±30min)、170hour. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of MB07133 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ding Yanhua | Contact | 18743062721 | 1023307193@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Jilin City | Changchun | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| 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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MB07133 600mg/m2/day+Sintilimab 200mg、 MB07133 1200mg/m2/day+Sintilimab 200mg、 MB07133 1800mg/m2/day+Sintilimab 200mg
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Pharmacokinetics of MB07133 |
| Within 0.5 hours before infusion,0.5hour (± 5 min) after the start of infusion,1hour(± 5min)、2hour(±5min)、4hour(±5min)、8hour(±5min)、12hour(±5min)、23hour(±30min)、 47hour(±30min)、71hour(±30min)、119hour(±30min)、143hour(±30min)、168hour |