PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
ConditionLiver Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital
About this trial
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
Eligibility criteria
Qualifiers
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 and a layer thickness of no more than 5mm);
ECOG physical condition score: 0 to 1;
Disqualifiers
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 years prior to enrollment);
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 ventricular arrhythmias requiring treatment or intervention.
For female subjects: women who are pregnant or breastfeeding.
Trial design
Treatments tested in this trial
- Low Dose PD-1 mRNA LNP Vaccine
- High dose PD-1 mRNA LNP vaccines
Treatment groups
9 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov