Liver CancerPhase 1NCT07053072
PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
A Phase 1 study testing Low Dose PD-1 mRNA LNP Vaccine and High dose PD-1 mRNA LNP vaccines in people with Liver Cancer, run by West China Hospital at 2 sites in China.
Trial summary
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Low Dose PD-1 mRNA LNP Vaccine and High dose PD-1 mRNA LNP vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 23 Oct 2025to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients: ≥18 years of age; ≤70 years of age;
- Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
- Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm);
- ECOG physical condition score: 0 to 1;
- Expected survival ≥ 3 months;
- Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
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- Routine blood tests: hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count >1.5×109 /L; platelet count ≥80×109 /L;
- Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
- cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.
- Good compliance and family agreement to cooperate in receiving survival follow-up.
Who cannot join
- Participation in a clinical trial of another drug within 4 weeks;
- Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5 years prior to enrollment);
- Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or ventricular arrhythmias requiring treatment or intervention.
- For female subjects: women who are pregnant or breastfeeding.
- Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
- Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
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- Subjects with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to : uveitis, enteritis, pituitary gland inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has resolved completely in childhood and does not require any intervention in adulthood may be enrolled; subjects with asthma requiring medical intervention with bronchodilators may not be enrolled).
- Patients who have been inoculated with mRNA drugs.
- Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine.
- Contraindications to intramuscular injection.
- History of substance abuse or known medical, psychological or social conditions such as alcohol or drug abuse.
- Known allergy, hypersensitivity or intolerance to the investigational vaccine (including any excipients). Previous history of severe allergy to any drug, food, or vaccination, such as anaphylaxis, allergic laryngeal edema, allergic dyspnea, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction).
- The female subject is planning to become pregnant or the male subject's partner is planning to become pregnant during the Screening Period and up to 12 months after the full course of drug administration.
- In the judgment of the investigator, there is a serious concomitant disease that jeopardizes the patient's safety or interferes with the patient's ability to complete the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen, 18980606753, pxx2014@163.com
- Recruiting
Sichuan University West China Hospital
Chengdu, Sichuan
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
Official title: A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
Read the detailed description
PD-1 mRNA LNP is an immune checkpoint mRNA vaccine loaded with the gene coding for the PD-1 protein Safety, tolerability, immunogenicity and preliminary efficacy of mRNA vaccines with PD-1 as the immunogen in the treatment of primary liver cancer. The aim of this study is to establish a novel PD-1-based mRNA for the treatment of advanced cancers.
- Conditions
- Liver Cancer
- Being tested
- Low Dose PD-1 mRNA LNP Vaccine, High dose PD-1 mRNA LNP vaccines
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose PD-1 mRNA LNP VaccineDrug
Also called PD-1 mRNA LNP vaccine at 50 mcg
Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
High dose PD-1 mRNA LNP vaccinesDrug
Also called PD-1 mRNA LNP vaccine at 100 mcg
Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Low-dose PD-1 mRNA LNP vaccine for advanced primary hepatocellular carcinoma failing standard therapy Receives: Drug: Low Dose PD-1 mRNA LNP Vaccine |
| High Dose | Experimental | High Dose PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma Failing Standard Treatment Receives: Drug: High dose PD-1 mRNA LNP vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events defined as the number of participants with adverse events
Measured: One month after the first vaccine dose
Secondary outcomes (7)
Disease Control Rate (DCR)
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overalresponse.
Measured: Two month after the first vaccine dose
DRR (Durable Response Rate)
DRR is defined as the proportion of objective response (CR and PR as determined by the investigator) lasting at least 6 months at any time within 12 months of initiation of treatment.
Measured: Six month after the first vaccine dose
DOR (Duration of Response)
DOR is defined as the time from the date when the PR is first recorded or better to the date when the disease progression is first recorded (for the responder, i.e., PR or better). Responders who did not record disease progress will be censored on the date that the last assessment was SD or better.
Measured: Six month after the first vaccine dose
TTR (Response Time）
TTR is defined as the time from the date of the first administration to the date of the first record of the objective tumor response (CR and PR determined by the investigator).
Measured: Six month after the first vaccine dose
PFS (progression-free survival)
PFS is defined as the duration until disease progression or death in participants fromthe first dose of immunization.
Measured: Six month after the first vaccine dose
OS (Overall Survival)
0S is defined as the duration until death in participants from the first dose ofimmunization.
Measured: Six month after the first vaccine dose
TTP (Time to Progression)
TTP is defined as the time from the date of first dose to the date of first documented disease progression, as defined by standard disease criteria.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start23 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by West China 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This single-centre, open-label, single-arm trial uses a dose-escalation framework to evaluate the safety and biological activity of PD-1 mRNA LNP in the treatment of patients with advanced hepatocellular carcinoma who have failed standard therapy. All participants will maintain a fixed chemotherapy/immunotherapy regimen based on their respective malignancies, with only the dose of PD-1 mRNA LNP changing. Three cases will be enrolled in each dose group, with the planned dose groups being the 50 μg and 100 μg groups. It consisted of 5 doses of basal immunisation and subsequent personalised treatment. For the base immunisation, the first 4 doses were administered 1 week apart each and the 5th dose was administered 1 month after the 4th dose. Dose-limiting toxicity (DLT) will be monitored through a 21-day monitoring window. Escalation decisions will be made using a Bayesian Optimal Interval (BOIN) approach, with DLT classification following the
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053072
- Sponsor's protocol ID
- 2025-755
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Wu Y, Yang T, Wei M, Wang Y, Deng X, Shen C, Li W, Zhang H, Xu W, Gou L, Zeng Y, Zhang Y, Wang Z, Yang J. Salidroside alleviates cachexia symptoms in mouse models of cancer cachexia via activating mTOR signalling. J Cachexia Sarcopenia Muscle. 2016 May;7(2):225-32. doi: 10.1002/jcsm.12054. Epub 2016 Jan 18.
PubMed 27493875Wu Y, Li W, Chen X, Wang H, Su S, Xu Y, Deng X, Yang T, Wei M, Li L, Liu Y, Yang J, Li W. DOG1 as a novel antibody-drug conjugate target for the treatment of multiple gastrointestinal tumors and liver metastasis. Front Immunol. 2023 Jan 26;14:1051506. doi: 10.3389/fimmu.2023.1051506. eCollection 2023.
PubMed 36776873Sabnis S, Kumarasinghe ES, Salerno T, Mihai C, Ketova T, Senn JJ, Lynn A, Bulychev A, McFadyen I, Chan J, Almarsson O, Stanton MG, Benenato KE. A Novel Amino Lipid Series for mRNA Delivery: Improved Endosomal Escape and Sustained Pharmacology and Safety in Non-human Primates. Mol Ther. 2018 Jun 6;26(6):1509-1519. doi: 10.1016/j.ymthe.2018.03.010. Epub 2018 Mar 14.
PubMed 29653760Selvaggio G, Leonardelli L, Lofano G, Fresnay S, Parolo S, Medini D, Siena E, Marchetti L. A quantitative systems pharmacology approach to support mRNA vaccine development and optimization. CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1448-1451. doi: 10.1002/psp4.12721. Epub 2021 Oct 21. No abstract available.
PubMed 34672423Xu S, Yang K, Li R, Zhang L. mRNA Vaccine Era-Mechanisms, Drug Platform and Clinical Prospection. Int J Mol Sci. 2020 Sep 9;21(18):6582. doi: 10.3390/ijms21186582.
PubMed 32916818Linares-Fernandez S, Lacroix C, Exposito JY, Verrier B. Tailoring mRNA Vaccine to Balance Innate/Adaptive Immune Response. Trends Mol Med. 2020 Mar;26(3):311-323. doi: 10.1016/j.molmed.2019.10.002. Epub 2019 Nov 5.
PubMed 31699497Verbeke R, Hogan MJ, Lore K, Pardi N. Innate immune mechanisms of mRNA vaccines. Immunity. 2022 Nov 8;55(11):1993-2005. doi: 10.1016/j.immuni.2022.10.014.
PubMed 36351374Lim SA, Cox A, Tung M, Chung EJ. Clinical progress of nanomedicine-based RNA therapies. Bioact Mater. 2021 Oct 22;12:203-213. doi: 10.1016/j.bioactmat.2021.10.018. eCollection 2022 Jun.
PubMed 35310381Sebastian M, Schroder A, Scheel B, Hong HS, Muth A, von Boehmer L, Zippelius A, Mayer F, Reck M, Atanackovic D, Thomas M, Schneller F, Stohlmacher J, Bernhard H, Groschel A, Lander T, Probst J, Strack T, Wiegand V, Gnad-Vogt U, Kallen KJ, Hoerr I, von der Muelbe F, Fotin-Mleczek M, Knuth A, Koch SD. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunol Immunother. 2019 May;68(5):799-812. doi: 10.1007/s00262-019-02315-x. Epub 2019 Feb 15.
PubMed 30770959Hong HS, Koch SD, Scheel B, Gnad-Vogt U, Schroder A, Kallen KJ, Wiegand V, Backert L, Kohlbacher O, Hoerr I, Fotin-Mleczek M, Billingsley JM. Distinct transcriptional changes in non-small cell lung cancer patients associated with multi-antigenic RNActive(R) CV9201 immunotherapy. Oncoimmunology. 2016 Nov 18;5(12):e1249560. doi: 10.1080/2162402X.2016.1249560. eCollection 2016.
PubMed 28123889Lorentzen CL, Haanen JB, Met O, Svane IM. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment. Lancet Oncol. 2022 Oct;23(10):e450-e458. doi: 10.1016/S1470-2045(22)00372-2.
PubMed 36174631Yuan Y, Gao F, Chang Y, Zhao Q, He X. Advances of mRNA vaccine in tumor: a maze of opportunities and challenges. Biomark Res. 2023 Jan 18;11(1):6. doi: 10.1186/s40364-023-00449-w.
PubMed 36650562Miao L, Zhang Y, Huang L. mRNA vaccine for cancer immunotherapy. Mol Cancer. 2021 Feb 25;20(1):41. doi: 10.1186/s12943-021-01335-5.
PubMed 33632261
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy
- ClinicalTrials.gov ID
- NCT07053072
- Acronym / sponsor ID
- 2025-755
- Conditions
- Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
Detailed description
PD-1 mRNA LNP is an immune checkpoint mRNA vaccine loaded with the gene coding for the PD-1 protein Safety, tolerability, immunogenicity and preliminary efficacy of mRNA vaccines with PD-1 as the immunogen in the treatment of primary liver cancer. The aim of this study is to establish a novel PD-1-based mRNA for the treatment of advanced cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This single-centre, open-label, single-arm trial uses a dose-escalation framework to evaluate the safety and biological activity of PD-1 mRNA LNP in the treatment of patients with advanced hepatocellular carcinoma who have failed standard therapy. All participants will maintain a fixed chemotherapy/immunotherapy regimen based on their respective malignancies, with only the dose of PD-1 mRNA LNP changing. Three cases will be enrolled in each dose group, with the planned dose groups being the 50 μg and 100 μg groups. It consisted of 5 doses of basal immunisation and subsequent personalised treatment. For the base immunisation, the first 4 doses were administered 1 week apart each and the 5th dose was administered 1 month after the 4th dose. Dose-limiting toxicity (DLT) will be monitored through a 21-day monitoring window. Escalation decisions will be made using a Bayesian Optimal Interval (BOIN) approach, with DLT classification following the
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Low Dose PD-1 mRNA LNP VaccineLow-dose PD-1 mRNA LNP vaccine for advanced primary hepatocellular carcinoma failing standard therapy |
| High Dose | Experimental | Drug: High dose PD-1 mRNA LNP vaccinesHigh Dose PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma Failing Standard Treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients: ≥18 years of age; ≤70 years of age;
- Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
- Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm);
- ECOG physical condition score: 0 to 1;
- Expected survival ≥ 3 months;
Key exclusion criteria (14 listed)
- Participation in a clinical trial of another drug within 4 weeks;
- Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5 years prior to enrollment);
- Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or ventricular arrhythmias requiring treatment or intervention.
- For female subjects: women who are pregnant or breastfeeding.
- Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
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 |
|---|---|---|
| Low Dose PD-1 mRNA LNP VaccineAlso: PD-1 mRNA LNP vaccine at 50 mcgPatients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose. | Drug | Low Dose |
| High dose PD-1 mRNA LNP vaccinesAlso: PD-1 mRNA LNP vaccine at 100 mcgPatients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose. | Drug | High Dose |
Primary outcome
Adverse events
Time frame: One month after the first vaccine dose
Adverse events defined as the number of participants with adverse events
7 secondary outcomes
Disease Control Rate (DCR)
Time frame: Two month after the first vaccine dose
DRR (Durable Response Rate)
Time frame: Six month after the first vaccine dose
DOR (Duration of Response)
Time frame: Six month after the first vaccine dose
TTR (Response Time）
Time frame: Six month after the first vaccine dose
PFS (progression-free survival)
Time frame: Six month after the first vaccine dose
OS (Overall Survival)
Time frame: Six month after the first vaccine dose
TTP (Time to Progression)
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Results publication: PubMed 27493875Chen X, Wu Y, Yang T, Wei M, Wang Y, Deng X, Shen C, Li W, Zhang H, Xu W, Gou L, Zeng Y, Zhang Y, Wang Z, Yang J. Salidroside alleviates cachexia symptoms in mouse models of cancer cachexia via activating mTOR signalling. J Cachexia Sarcopenia Muscle. 2016 May;7(2):225-32. doi: 10.1002/jcsm.12054. Epub 2016 Jan 18.
- Results publication: PubMed 36776873Wu Y, Li W, Chen X, Wang H, Su S, Xu Y, Deng X, Yang T, Wei M, Li L, Liu Y, Yang J, Li W. DOG1 as a novel antibody-drug conjugate target for the treatment of multiple gastrointestinal tumors and liver metastasis. Front Immunol. 2023 Jan 26;14:1051506. doi: 10.3389/fimmu.2023.1051506. eCollection 2023.
- Results publication: PubMed 29653760Sabnis S, Kumarasinghe ES, Salerno T, Mihai C, Ketova T, Senn JJ, Lynn A, Bulychev A, McFadyen I, Chan J, Almarsson O, Stanton MG, Benenato KE. A Novel Amino Lipid Series for mRNA Delivery: Improved Endosomal Escape and Sustained Pharmacology and Safety in Non-human Primates. Mol Ther. 2018 Jun 6;26(6):1509-1519. doi: 10.1016/j.ymthe.2018.03.010. Epub 2018 Mar 14.
- Results publication: PubMed 34672423Selvaggio G, Leonardelli L, Lofano G, Fresnay S, Parolo S, Medini D, Siena E, Marchetti L. A quantitative systems pharmacology approach to support mRNA vaccine development and optimization. CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1448-1451. doi: 10.1002/psp4.12721. Epub 2021 Oct 21. No abstract available.
- Results publication: PubMed 32916818Xu S, Yang K, Li R, Zhang L. mRNA Vaccine Era-Mechanisms, Drug Platform and Clinical Prospection. Int J Mol Sci. 2020 Sep 9;21(18):6582. doi: 10.3390/ijms21186582.
- Results publication: PubMed 31699497Linares-Fernandez S, Lacroix C, Exposito JY, Verrier B. Tailoring mRNA Vaccine to Balance Innate/Adaptive Immune Response. Trends Mol Med. 2020 Mar;26(3):311-323. doi: 10.1016/j.molmed.2019.10.002. Epub 2019 Nov 5.
- Results publication: PubMed 36351374Verbeke R, Hogan MJ, Lore K, Pardi N. Innate immune mechanisms of mRNA vaccines. Immunity. 2022 Nov 8;55(11):1993-2005. doi: 10.1016/j.immuni.2022.10.014.
- Results publication: PubMed 35310381Lim SA, Cox A, Tung M, Chung EJ. Clinical progress of nanomedicine-based RNA therapies. Bioact Mater. 2021 Oct 22;12:203-213. doi: 10.1016/j.bioactmat.2021.10.018. eCollection 2022 Jun.
- Results publication: PubMed 30770959Sebastian M, Schroder A, Scheel B, Hong HS, Muth A, von Boehmer L, Zippelius A, Mayer F, Reck M, Atanackovic D, Thomas M, Schneller F, Stohlmacher J, Bernhard H, Groschel A, Lander T, Probst J, Strack T, Wiegand V, Gnad-Vogt U, Kallen KJ, Hoerr I, von der Muelbe F, Fotin-Mleczek M, Knuth A, Koch SD. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunol Immunother. 2019 May;68(5):799-812. doi: 10.1007/s00262-019-02315-x. Epub 2019 Feb 15.
- Results publication: PubMed 28123889Hong HS, Koch SD, Scheel B, Gnad-Vogt U, Schroder A, Kallen KJ, Wiegand V, Backert L, Kohlbacher O, Hoerr I, Fotin-Mleczek M, Billingsley JM. Distinct transcriptional changes in non-small cell lung cancer patients associated with multi-antigenic RNActive(R) CV9201 immunotherapy. Oncoimmunology. 2016 Nov 18;5(12):e1249560. doi: 10.1080/2162402X.2016.1249560. eCollection 2016.
- Results publication: PubMed 36174631Lorentzen CL, Haanen JB, Met O, Svane IM. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment. Lancet Oncol. 2022 Oct;23(10):e450-e458. doi: 10.1016/S1470-2045(22)00372-2.
- Results publication: PubMed 36650562Yuan Y, Gao F, Chang Y, Zhao Q, He X. Advances of mRNA vaccine in tumor: a maze of opportunities and challenges. Biomark Res. 2023 Jan 18;11(1):6. doi: 10.1186/s40364-023-00449-w.
- Individual participant dataSharing planned: No
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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.
Xingchen Peng principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Dose PD-1 mRNA LNP Vaccine and High dose PD-1 mRNA LNP vaccines in people with Liver Cancer, run by West China Hospital at 2 sites in China.
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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: One month after the first vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07053072, which also lists 13 linked publications.
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 13 Oct 2026.