An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma
Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure specified in the test);
Age 18-75 years old (inclusive);
Patients with primary or metastatic liver cancer confirmed histologically or cytologically;
Patients with liver cancer who have failed standard treatment, are not suitable for or are not willing to accept standard treatment;
A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency within 6 months prior to screening;
Patients with large tumors - tumors >50% by liver volume and/or invading inferior vena cava;
Non-recovery to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) level 1 toxicity (excluding hair loss, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antitumor therapy prior to initial administration of the study drug;
Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively controlled) in the past 5 years;
Single group
OH2 injection
Biological/VaccineOH2 injection administered by transcatheter Intraarterial infusion
DLTs (Dose Limiting Toxicity)
Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol
MTD (Maximum Tolerance dose)
If ≥2/6 subjects developed DLT, the previous dose group was MTD
Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)
According to the NCI-CTCAE 5.0 grading standard
Objective Response Rate
The assessment result is the number and proportion of subjects with complete response + partial response.
Disease Control Rate
The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.
OS (Overall Survival)
The overall survival for each patient receiving OH2 will be calculated.
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