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Trial Title:
Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation
NCT ID:
NCT05761717
Condition:
Posto Perative Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
Description:
Subcutaneous Injection
Arm group label:
3+3
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 20, 2023
Completion date:
June 12, 2025
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761717
