OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBinhui Biopharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • OH2 injection

Treatment groups

12 Participants
are divided into 1 treatment group