Advanced Hepatocellular Carcinoma
Conditions
Keywords
HCC
Brief summary
This study is an open, multi-center phase I/II clinical study.
Detailed description
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).
Interventions
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.
DRUGToripalimab Injection
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the Standards for the Diagnosis and Treatment of Primary Liver Cancer (2017); * At least one measurable lesion (according to RECIST v1.1); * ECOG performance status score of 0 or 1; * Life expectancy ≥ 12 weeks； * Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs； * Fully understand this research and voluntarily sign the ICF。
Exclusion criteria
* Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver. * Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type； * Tumor invades inferior vena cava VP4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | 28 days after the first dose of JS001 and Donafenib | Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial |
| Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1 | 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 | The ratio of patients who are evaluated as CR or PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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 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 | The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death |
Countries
China
Contacts
Primary ContactShukui Qin, PhD
Outcome results
None listed