Posto Perative Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGNeoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
Subcutaneous Injection
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year recurrence-free survival rate (RFS); | 1 year |
| Overall survival (OS) after initial administration. | 1 year |
Contacts
Primary ContactJia Fan, MD
Backup ContactQiang Gao, MD
Outcome results
None listed