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

Not Applicable

Not yet recruiting

• Conditions: Posto Perative Hepatocellular Carcinoma
• Interventions: Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection

• Registration Number: NCT05761717
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Study Start: 2023-04-20
• Primary Completion: 2025-03-12
• Study Completion: 2025-06-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 67

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
3+3	Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection	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

Primary Outcome Measures

Name	Time	Method
One-year recurrence-free survival rate (RFS);	1 year
Overall survival (OS) after initial administration.	1 year