Posto Perative Hepatocellular CarcinomaNCT05761717
Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation
A study testing Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection in people with Posto Perative Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posto Perative Hepatocellular Carcinoma
- What is being tested?
- Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
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.
- Conditions
- Posto Perative Hepatocellular Carcinoma
- Being tested
- Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njectionDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year recurrence-free survival rate (RFS);
Measured: 1 year
Overall survival (OS) after initial administration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start20 Apr 2023 (estimated)
- Primary completion12 Mar 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posto Perative Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761717
- Sponsor's protocol ID
- 2021-10-mRNA-COM
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
- ClinicalTrials.gov ID
- NCT05761717
- Acronym / sponsor ID
- 2021-10-mRNA-COM
- Conditions
- Posto Perative Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 12 Mar 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3+3 | Experimental | Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njectionNeoantigen 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njectionSubcutaneous Injection | Drug | 3+3 |
Primary outcome
One-year recurrence-free survival rate (RFS);
Time frame: 1 year
Overall survival (OS) after initial administration.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab I njection in people with Posto Perative Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Fan, MD (8618817583741, fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year recurrence-free survival rate (RFS); (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.