Unresectable Hepatocellular Carcinoma
Conditions
Brief summary
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.
Detailed description
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).
Interventions
100mg Qd/150mg Qd/100mg Bid, po
BIOLOGICALToripalimab Injection
240 mg, iv drip,q3w
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 (inclusive), male or female; * Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the Guidelines for diagnosis and treatment of primary liver cancer (2019 Edition); * At least one measurable lesion (according to RECIST v1.1) * ECOG performance status score of 0 -1; * Life expectancy ≥ 12 weeks; * Fully understand this research and voluntarily sign the ICF.
Exclusion criteria
* Diffuse liver cancer； * Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome； * Pregnancy or lactation； * Patients with extrahepatic diffusion； * Spontaneous tumor rupture； * Expected non-compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity(DLT) | 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years | Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From the date of randomization until death due to any cause, assessed up to 2 years. | The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date. |
| Progression free survival (PFS) | From date of randomization until the date of objective disease progression or death, assessed up to 2 years. | The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death |
| Duration of response (DOR) | 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. | 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 |
Countries
China
Outcome results
None listed