Clinical trial
A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma
Name
JS001D-C-102
Description
This study is an open, multi-center phase I/II clinical study.
Trial arms
Trial start
2020-10-15
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Donafenib Tosilate Tablets
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.
Arms:
JS001+Donafenib
Other names:
Donafenib
Toripalimab Injection
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
Arms:
JS001+Donafenib
Other names:
JS001
Size
46
Primary endpoint
Dose limiting toxicity (DLT)
28 days after the first dose of JS001 and Donafenib
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}
Updated at
2022-11-29
1 organization
2 products
1 indication
Product
DonafenibIndication
Hepatocellular CarcinomaProduct
ToripalimabOrganization
Suzhou Zelgen Biopharmaceuticals