Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Low Dose PD-1 mRNA LNP Vaccine

    Drug

    Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.

  • High dose PD-1 mRNA LNP vaccines

    Drug

    Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.

Treatment groups

9 Participants
are divided into 2 treatment groups
Group A: Low DoseExperimental treatment 1 intervention
Group B: High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Adverse events defined as the number of participants with adverse events

Time frame
One month after the first vaccine dose

Secondary outcomes

1

Disease Control Rate (DCR)

The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overalresponse.

Time frame
Two month after the first vaccine dose
2

DRR (Durable Response Rate)

DRR is defined as the proportion of objective response (CR and PR as determined by the investigator) lasting at least 6 months at any time within 12 months of initiation of treatment.

Time frame
Six month after the first vaccine dose
3

DOR (Duration of Response)

DOR is defined as the time from the date when the PR is first recorded or better to the date when the disease progression is first recorded (for the responder, i.e., PR or better). Responders who did not record disease progress will be censored on the date that the last assessment was SD or better.

Time frame
Six month after the first vaccine dose
4

TTR (Response Time）

TTR is defined as the time from the date of the first administration to the date of the first record of the objective tumor response (CR and PR determined by the investigator).

Time frame
Six month after the first vaccine dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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