Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation

NCT ID: NCT05761717

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2025-06-12

Brief Summary

This is an open, one-arm study to evaluate the safety and efficacy of mRNA personalized tumor vaccine (tumor vaccine) encoding neonatal antigen in combination with Sintilimab injection for adjuvant prevention of postoperative recurrence of hepatocellular carcinoma.

Conditions

Posto Perative Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3+3

Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. This study is a 3+3 dose escalation design.Participants will receive a total of 6 cycles of PCV every 21 days

Group Type: EXPERIMENTAL

Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection

Intervention Type: DRUG

Subcutaneous Injection

Interventions

Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection

Subcutaneous Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are ≥18 years old (including boundary values), without limitation of sex at time of consent.
• The patient was confirmed as hepatocellular carcinoma by histopathology or cytology after surgery, and the lesion was completely resected by surgery R0 (no residual tumor under postoperative microscope and naked eye), and no residual lesion or extrahepatic metastasis was confirmed by postoperative imaging (CT/MRI).
• The patient is at high risk of postoperative recurrence, and the tumor must meet the following characteristics: Patients with hepatocellular carcinoma IIb/IIIa as defined by the 2019 Chinese Staging System.
• The Eastern Oncology Consortium Physical State Score (ECOG PS) is 0 or 1, and the Child-Pugh rating is A

Exclusion Criteria

• Known allergy to any tumor vaccine, adjuvant, Stintilimab Injection formulation, fluorouracil inj, oxaliplatin injcalcies;
• Tumor mutation load (TMB) was less than 2.0/Mb or neonatal antigen load (TNB) was less than 0.5/Mb or the predicted number of neonatal antigens was less than 15;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jia Fan, MD

Role: CONTACT

fan.jia@zs-hospital.sh.cn

8618817583741

Qiang Gao, MD

Role: CONTACT

gaoqiang@fudan.edu.cn

8613816266282

Other Identifiers

2021-10-mRNA-COM

Identifier Type: -

Identifier Source: org_study_id