Actively Recruiting
OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2024-12-20
12
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and have voluntarily signed informed consent before any study procedures
- Age between 18 and 75 years old inclusive
- Diagnosed with primary or metastatic liver cancer confirmed by tissue or cell analysis
- Liver cancer patients who have failed standard treatment, are unsuitable for, or unwilling to accept standard treatment
- ECOG physical status of 0 or 1
- Child-Pugh liver function Grade A or B
- Adequate bone marrow, liver, kidney, and organ functions with specified laboratory values within 7 days before first dose
- Chronic HBV patients must have HBV-DNA < 500 IU/ml and receive antiviral therapy if HBsAg positive; HCV-RNA positive patients must receive antiviral therapy and have normal liver function
- Recovery from previous chemotherapy or radiotherapy adverse effects to NCI CTCAE V5.0 Grade 1 or less (except hair loss and non-significant lab abnormalities)
- At least 3 months since completion of herpes treatment if applicable
- Expected survival of at least 12 weeks
- Fertile women must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during the study and 90 days after
- At least 4 weeks since last anti-tumor therapy (6 weeks for nitrosourea or mitomycin chemotherapy)
- At least 4 weeks since major surgery
- At least one measurable or evaluable lesion according to RECIST 1.1 criteria
You will not qualify if you...
- History of pleural effusion from moderate/severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver failure within 6 months before screening
- Liver tumors larger than 50% of liver volume or invading the inferior vena cava
- Unresolved toxicity from prior anti-tumor therapy above NCI CTCAE V5.0 Grade 1 (excluding hair loss and non-significant lab abnormalities)
- Other malignancies within past 5 years except controlled basal/squamous cell skin cancer or cervical carcinoma in situ
- Known central nervous system metastases with recent progression or unstable symptoms; cancerous meningitis excluded
- Anti-tumor treatments for liver cancer within 4 weeks before first dose, except certain traditional Chinese medicine with 1-week washout
- Radical radiotherapy within 4 weeks before first dose
- Previous treatment with similar antitumor drugs
- Major surgery or unhealed wounds within 4 weeks before first dose
- Active gastrointestinal diseases or bleeding risks determined by investigators
- Significant bleeding events within 2 months or thromboembolic events within 12 months before first dose
- Significant cardiovascular diseases within 6 months before first dose
- Severe electrolyte imbalances judged clinically significant
- Active infection or unexplained fever >38.5°C prior to first dose
- Previous or planned allogeneic organ or bone marrow transplantation
- Pulmonary diseases that could interfere with drug toxicity detection
- Active tuberculosis under treatment or recent treatment within 1 year; known HIV infection; active hepatitis B or C virus
- Pregnant or breastfeeding women
- Known allergy to herpes virus or OH2 injection ingredients
- Other medical or metabolic conditions judged unsuitable by investigator
- Participation in other clinical trials with unapproved drugs within 4 weeks before first dose
- Any other factors possibly leading to early study termination as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
chuansheng zheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here