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This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.
The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donafenib/JS001/TACE | Experimental | Donafenib and JS001 Combined With TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib Tosilate Tablets | Drug | 100mg Qd/150mg Qd/100mg Bid, po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity(DLT) | Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity. | 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date. | From the date of randomization until death due to any cause, assessed up to 2 years. |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanzhi Gu, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab Injection |
| Biological |
240 mg, iv drip,q3w |
|
|
The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death |
| From date of randomization until the date of objective disease progression or death, assessed up to 2 years. |
| Duration of response (DOR) | defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death | From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years. |