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

Primary Purpose

Posto Perative Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posto Perative Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    3+3

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    February 27, 2023
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05761717
    Brief Title
    Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation
    Official Title
    Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 20, 2023 (Anticipated)
    Primary Completion Date
    March 12, 2025 (Anticipated)
    Study Completion Date
    June 12, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posto Perative Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    67 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3+3
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
    Intervention Description
    Subcutaneous Injection
    Primary Outcome Measure Information:
    Title
    One-year recurrence-free survival rate (RFS);
    Time Frame
    1 year
    Title
    Overall survival (OS) after initial administration.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia Fan, MD
    Phone
    8618817583741
    Email
    fan.jia@zs-hospital.sh.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiang Gao, MD
    Phone
    8613816266282
    Email
    gaoqiang@fudan.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

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

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