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New treatment option for Liver Cancer
Official title PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
ClinicalTrials.gov ID: NCT07053072
What this study is testing
What is Low Dose PD-1 mRNA LNP Vaccine?
Low Dose PD-1 mRNA LNP Vaccine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for liver cancer.
Also referred to as PD-1 mRNA LNP vaccine at 50 mcg.
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
- Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
- 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 70
You may be able to join if
- Male or female patients: ≥18 years of age; ≤70 years of age;
- Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
- Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter...
- ECOG physical condition score: 0 to 1;
- Expected survival ≥ 3 months;
You likely can't join if
- Participation in a clinical trial of another drug within 4 weeks;
- Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or...
- Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial...
- For female people: women who are pregnant or breastfeeding.
- Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
- Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
See the full eligibility criteria
- Male or female patients: ≥18 years of age; ≤70 years of age;
- Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
- Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm...
- ECOG physical condition score: 0 to 1;
- Expected survival ≥ 3 months;
- Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
- Routine blood tests: hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count \>1.5×109 /L; platelet count ≥80×109 /L;
- Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous...
- cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.
- Good compliance and family agreement to cooperate in receiving survival follow-up.
- Participation in a clinical trial of another drug within 4 weeks;
- Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5...
- Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or...
- For female people: women who are pregnant or breastfeeding.
- Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
- Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
- people with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to : uveitis, enteritis, pituitary gland inflammation, nephritis, hyperthyroidism, hypothyroidism; people...
- Patients who have been inoculated with mRNA drugs.
- Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine.
- Contraindications to intramuscular injection.
- History of substance abuse or known medical, psychological or social conditions such as alcohol or drug abuse.
- Known allergy, hypersensitivity or intolerance to the investigational vaccine (including any excipients). Previous history of severe allergy to any drug, food, or vaccination, such as anaphylaxis, allergic laryngeal...
- The female subject is planning to become pregnant or the male subject's partner is planning to become pregnant during the Screening Period and up to 12 months after the full course of drug administration.
- In the judgment of the investigator, there is a serious concomitant disease that jeopardizes the patient's safety or interferes with the patient's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.