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New treatment option for Advanced Liver Cancer
Official title OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer
ClinicalTrials.gov ID: NCT05698459
What this study is testing
What is OH2 injection?
OH2 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced liver cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure...
- 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;
- ECOG physical condition 0 or 1;
You likely can't join if
- A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency...
- 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...
- Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively...
- For people with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging...
- Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, treatment therapy, systemic...
See the full eligibility criteria
Who can join
- 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;
- ECOG physical condition 0 or 1;
- Meet Child-Pugh liver function rating: Grade A or B;
- Adequate bone marrow, liver, kidney and organ functions, meeting the following requirements in laboratory examination within 7 days prior to the first medication (no blood transfusion, blood products, no correction of...
- Neutrophil absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L;
- Serum total bilirubin ≤3 times the upper limit of the normal reference range (3×ULN);
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤5×ULN;
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (as calculated by Cockcroft-Gault formula);
- International Normalized ratio (INR) ≤1.5 or partially activated prothrombin time (APTT) ≤1.5×ULN;
- people with chronic HBV infection must receive HBV-DNA \< 500IU/ml and HBsAg positive patients must receive antiviral therapy according to the Guidelines for Chronic Hepatitis B Prevention and Treatment 2015 Edition...
- Recovery of AE associated with previous systemic chemotherapy, radical/extensive radiotherapy to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) ≤ Class 1 (except hair loss, non-clinically...
- For people with herpes, 3 months after completion of herpes treatment;
- Expected survival ≥12 weeks;
- Fertile women must have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients volunteered to use effective contraceptive methods, such as dual screen...
- More than 4 weeks after the end of previous anti-tumor therapy (including endocrine, chemical/radiotherapy, targeted therapy) (more than 6 weeks after the treatment of nitrosourea and mitomycin chemotherapy);
- Four weeks after major surgery;
- At least one measurable or evaluable lesion was present according to RECIST1.1 criteria.
What rules you out
- 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...
- 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;
- For people with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging progression is seen at least 4 weeks before the first administration...
- Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, treatment therapy, systemic therapy, radiotherapy and traditional Chinese medicine therapy (the...
- Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks prior to initial medication;
- Have previously received similar drugs for antitumor therapy;
- Received major surgical operations (the definitions of major surgical operations refer to Grade 3 and Grade 4 operations specified in the "Measures for the Clinical Application of Medical Technology" implemented on May...
- The people currently have active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases, or active bleeding from unexcised tumors, or other conditions determined by the researchers that may...
- Patients with significant evidence or history of bleeding tendency within 2 months prior to initial medication (bleeding \>30mL within 2 months, hematemesis, black feces, and hematochezia), hemoptysis (\>5mL of fresh...
- Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to initial...
- Severe and uncorrectable electrolyte abnormalities determined by the investigator to be clinically significant;
- The patient had an active infection or developed an unexplained fever (body temperature \>38.5oC) during screening and prior to initial administration;
- Preparing for or having previously received allogeneic organ or bone marrow transplantation, including liver transplantation;
- people with a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that might interfere with the...
- Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to initial medication; Known human immunodeficiency virus (HIV) infection; The copy number of...
- Pregnant women (positive pregnancy test before medication) or breastfeeding women;
- Known allergy to any herpes virus and OH2 inJ ingredients;
- Any other medical condition, clinically significant metabolic abnormality (e.g., uncontrolled diabetes, thyroid dysfunction), physical abnormality, or laboratory abnormality, in which, in the investigator's judgment...
- Received the corresponding experimental drugs in clinical trials of other unapproved or unmarketed drugs within 4 weeks before the first drug use;
- As determined by the investigator, the people had other factors that might have led to the forced termination of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.