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

Fudan University

Status: Not yet enrolling

Conditions: Posto Perative Hepatocellular Carcinoma

Treatments: Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection

Study type: Interventional

Funder types: Other

Identifiers

NCT05761717

2021-10-mRNA-COM

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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67 participants in 1 patient group

3+3

Experimental group

Description:

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

Treatment:

Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection