Application of mRNA Immunotherapy Technology in Hepatitis B Virus-related Refractory Hepatocellular Carcinoma

NCT05738447 | Unknown Phase 1

• 1 other identifier: 2022-1371
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mRNA vaccine for HBV-positive Advanced Hepatocellular Carcinoma.

Conditions

Liver Cancer; Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; mRNA vaccine; HBV; immunotherapy

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Adverse events defined as the number of participants with adverse events according

  up to 12 months

• Objective response rate

  ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)

  up to 12 months

• Progress-Free Survival

  PFS is defined as the time from the administration of the first dose to first disease

  up to 12 months

• Overall Survival

  OS is defined as the time from the administration of the first dose to death

  up to 12 months]

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

With 20ug as the starting point, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose, and the intramuscular injection was administered again every 7 days, and after 4 doses, the 5th dose was given after 1-month interval.

Biological: HBV mRNA vaccine

Interventions

HBV mRNA vaccine BIOLOGICAL

With 20ug as the starting point, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose, and the intramuscular injection was administered again every 7 days, and after 4 doses, the 5th dose was given after 1-month interval.

Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients: ≥ 18 years old; ≤ 70 years old;
• Patients with HBV-positive advanced hepatocellular carcinoma after failure of second-line standard therapy (including PD-1 inhibitor therapy, chemotherapy, and anti-vascular targeted drugs);
• HBsAg positive, regardless of whether the peripheral blood is positive for HBV DNA.
• ECOG physical fitness score: 0\~1 points;
• Estimated survival ≥ 3 months;
• The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:
• Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14 days); Neutrophil count\> 1.5×109/L; Platelet count≥ 80×109/L;
• Biochemical examination: total bilirubin ≤ 1.5× ULN (upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; If liver metastases are present, ALT or AST ≤ 5×ULN; Endogenous creatinine clearance
• ≥ 60 ml/min (Cockcroft-Gault formula);
• Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥50%.
• Sign the informed consent form;
• Good compliance, family members agree to cooperate with survival follow-up.

You may not qualify if:

• Participated in clinical trials of other drugs within 4 weeks;
• The patient has a history of other tumors, unless it is cervical cancer in situ, treated cutaneous squamous cell carcinoma or bladder epithelial tumor or other malignant tumors that has received radical treatment (at least 5 years before enrollment)
• Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure above NYHA grade 2, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• For female subjects: pregnant or lactating women.
• The patient has active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); There is HIV infection with active HBV infection, HCV infection.
• Those who have a history of psychotropic drug abuse and have mental disorders that cannot be remitted;
• The subject has any active autoimmune disease or has a history of autoimmune disease (such as, but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; Participants with vitiligo or who had complete remission of asthma in childhood and did not require any intervention in adulthood could be included; Participants in asthma requiring medical intervention with bronchodilators omitted).
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the patient's research.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

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MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

+86 18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 22, 2023
• Study Start: February 15, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)