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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05761717
Collaborator
(none)
67
Enrollment
1
Arm
25.8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
67 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
12~18 participants in Cohort . C1:50 ug of PCV; C2: 100 ug of PCV ; C3: 150 ug of PCV.Extended research phase:49 participants in Cohort.12~18 participants in Cohort . C1:50 ug of PCV; C2: 100 ug of PCV ; C3: 150 ug of PCV.Extended research phase:49 participants in Cohort.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Mar 12, 2025
Anticipated Study Completion Date :
Jun 12, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

Outcome Measures

Primary Outcome Measures

  1. One-year recurrence-free survival rate (RFS); [1 year]

  2. Overall survival (OS) after initial administration. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT05761717
Other Study ID Numbers:
  • 2021-10-mRNA-COM
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms

Study Results

No Results Posted as of Mar 9, 2023