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This study is an open, multi-center phase I/II clinical study.
It will explore the tolerability (phase I) and effectiveness (phase II) of the Donafenib tosilate tablets combined with Toripalimab injection in patients with advanced HCC. The study is conducted in two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS001+Donafenib | Experimental | Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib Tosilate Tablets | Drug | In the dose exploration phase (phase I)，three doses of Donafenib tosylate tablets [100 mg once a day (QD); 100 mg twice a day (BID); 200 mg, BID] will be explored. In the dose expansion phase (phase II), patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial | 28 days after the first dose of JS001 and Donafenib |
| Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1 | The ratio of patients who are evaluated as CR or PR | From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-JS001 antibody | From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months | |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shukui Qin, PhD | Contact | +86-025-80864541 | qinsk@csco.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shukui Qin, PhD | No.81 Hospital of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.81 Hospital of PLA | Recruiting | Nanjing | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| C000710249 | donafenib |
| C000656314 | toripalimab |
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| Toripalimab Injection | Drug | JS001 will be administrated by intravenous (i.v.) infusion once every 21 days |
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The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
| From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months |
| Progression free survival (PFS) | The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death | From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months |