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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3+3 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection | Drug | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| One-year recurrence-free survival rate (RFS); | 1 year | |
| Overall survival (OS) after initial administration. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fan, MD | Contact | 8618817583741 | fan.jia@zs-hospital.sh.cn | |
| Qiang Gao, MD | Contact | 8613816266282 | gaoqiang@fudan.edu.cn |
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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.
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