Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant TherapyPhase 1PCV-GSTTNCT07067385
Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment
A Phase 1 study testing Neoantigen Personalized Cancer Vaccine in people with Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy and Gastrointestinal Tumors, run by Ruijin Hospital at 1 site in China.
Trial summary
Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy, Gastrointestinal Tumors
- What is being tested?
- Neoantigen Personalized Cancer Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signs the informed consent form, and has good compliance.
- Male or female, aged 18 years or older.
- Patients with advanced gastrointestinal tumors: histologically and/or cytologically confirmed recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment.
- Patients with resectable gastrointestinal solid tumors for adjuvant treatment: tumors must be confirmed as completely resected (R0 or R1) by postoperative histopathology, with no prior neoadjuvant therapy, and assessed as fully resectable by imaging.
- Neoantigen load requirement: at least 10 predicted neoantigen epitopes.
- The subject must have a tumor lesion suitable for repeated sampling for sequencing and immune testing. Fresh or archived tumor tissue is required, preferably from surgical or core needle biopsy (CNB) samples, including both tumor and 2-3 soybean-sized peritumoral tissues. Paraffin blocks or at least 10-20 unstained tumor tissue sections (4-6 μm thick) with tumor content >20% are acceptable. If the subject cannot provide suitable samples but meets other inclusion/exclusion criteria, the investigator may still consider enrollment.
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- ECOG performance status of 0 or 1.
- Life expectancy of at least 6 months.
- Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:
- 1). Hematology: ANC ≥ 1.5 × 10⁹/L, WBC ≥ 3 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L. Within one week before screening, the subject must not have received blood or platelet transfusions, G-CSF, or erythropoietin (EPO); 2). Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); 3). Liver function: AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL < 3 × ULN); 4). Coagulation: INR ≤ 2 × ULN or APTT ≤ 1.5 × ULN (except for patients on anticoagulants); 5). Endocrine function: TSH within normal limits. Note: If baseline TSH is outside the normal range but free T3 and free T4 are within normal limits, the subject is still eligible.
- 9. Agrees to provide peripheral blood samples and, optionally, fresh peritumoral tissue for sequencing.
- 10. Male subjects with reproductive potential and female subjects of childbearing potential agree to use effective contraception from the time of informed consent until 6 months after the last dose of investigational drug.
- Women of childbearing potential include premenopausal women and those within 2 years post-menopause.
- A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.
Who cannot join
- Known allergy or hypersensitivity to any investigational drug or its components used in this study.
- Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.
- Receipt of the following therapies or interventions within 28 days before the first dose of study drug:
- Participation in an interventional clinical study;
- Major surgery or traumatic injury, or expected to undergo major surgery during the study (minor procedures such as core needle biopsy or placement of a vascular access device within 7 days before the first dose are permitted);
- Vaccination with a live attenuated vaccine, or planned vaccination during the study or within 5 months after the last dose of study treatment;
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- Systemic antitumor therapy (including chemotherapy, small molecule targeted therapy, antibody therapy, cellular immunotherapy, hormonal therapy), or local antitumor therapy (e.g., radiotherapy). Palliative radiotherapy for bone metastases completed >2 weeks before baseline tumor assessment is allowed. Also includes prior treatment with systemic immune-stimulating agents (e.g., interferons or interleukin-2).
- Presence of severe chronic or active infection within 28 days before the first dose, including but not limited to hospitalization due to infection, sepsis, or severe pneumonia, or any active infection deemed to compromise patient safety by the investigator. Systemic antibiotic treatment within 2 weeks before study start.
- Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.
- Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if neurologically stable for at least 3 months, show no evidence of progression by imaging within 4 weeks before study drug initiation, have recovered from all neurologic symptoms, show no evidence of new or enlarging lesions, and have discontinued corticosteroids, surgery, or radiotherapy for at least 28 days. Carcinomatous meningitis is exclusionary regardless of stability.
- Active hepatitis B virus (HBV) infection (defined as HBsAg positive and HBV-DNA > 500 IU/mL), hepatitis C virus (HCV) infection (defined as HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV) infection (HIV-Ab positive), active tuberculosis, or any other active infection requiring systemic treatment within 14 days before first study drug administration (prophylactic anti-infective treatment is allowed).
- History of clinically significant cardiovascular or cerebrovascular disease within 6 months before the first dose, including but not limited to:
- Acute myocardial infarction;
- Unstable angina;
- Stroke (excluding asymptomatic lacunar infarction not requiring intervention);
- History of significant ventricular arrhythmias (e.g., sustained VT, VF, torsades de pointes);
- NYHA class III or IV congestive heart failure;
- QTcF ≥ 470 ms or history/family history of congenital long QT syndrome;
- Baseline left ventricular ejection fraction (LVEF) < 50% or significant wall motion abnormalities on echocardiography;
- Poorly controlled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg);
- Other arrhythmias deemed unsuitable by the investigator.
- Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within 2 years before the first study dose. Physiologic replacement therapy (e.g., levothyroxine, insulin, or corticosteroids for adrenal or pituitary insufficiency) is permitted.
- History of other malignancies within 3 years before study treatment, except for those with curative potential after radical treatment, such as basal or squamous cell skin cancers, localized low-risk prostate cancer, papillary thyroid carcinoma, or any in situ carcinoma (e.g., cervical carcinoma in situ or ductal carcinoma in situ).
- Any other severe or uncontrolled disease or condition that, in the opinion of the investigator, could interfere with study participation or compliance, including but not limited to:
- Severe respiratory disease, such as interstitial lung disease, severe asthma, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT;
- Severe venous or arterial thromboembolism, such as pulmonary embolism or deep vein thrombosis (excluding asymptomatic, untreated intermuscular venous thrombosis);
- Symptomatic or large pleural effusion or ascites requiring symptomatic management;
- Active or past history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);
- Symptomatic or significant pericardial, pleural, or abdominal effusion on screening;
- Tumors encasing major blood vessels or with extensive necrosis or cavitation on imaging, which the investigator considers to pose a bleeding risk;
- History of gastrointestinal perforation, surgical/wound healing complications, or significant bleeding events.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- History of substance abuse or psychiatric disorder that may interfere with compliance.
- Pregnant or breastfeeding women. Pregnancy is defined as the period from conception until the end of gestation. Pregnancy status must be confirmed by a serum hCG test within 7 days before study initiation.
- Prior treatment with cell therapies (e.g., TCR-T, CAR-T, TILs) or neoantigen-based cancer vaccines. Prior treatment with immune checkpoint inhibitors (e.g., PD-1, PD-L1). Receipt of immune-stimulating agents (e.g., thymosin, interferon, interleukin-2) within 6 weeks before study treatment.
- Genetic sequencing reveals functional defects in genes related to antigen presentation, antigen recognition, or cytotoxicity.
- Any other condition deemed inappropriate for study enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, SH
Hao Li, MD, PhD, 86-15000660260, lh11001@rjh.com.cn
Hao Li, MD, PhD
About this study
Official title: Exploratory Clinical Study of Neoantigen Tumor Vaccine Therapy for Gastrointestinal Solid Tumors
Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors
Read the detailed description
This is a single-center, open, single-arm exploratory clinical study to evaluate the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors, and to provide more clinical treatment options for gastrointestinal cancer patients.
- Conditions
- Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy, Gastrointestinal Tumors
- Being tested
- Neoantigen Personalized Cancer Vaccine
- Keywords
- neoantigen, p-MHC-TCR, CRC, mRNA, machine learning
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen Personalized Cancer VaccineBiological
Also called deepGeneAI-001
Cohort 1: subjects will receive neoantigen tumor vaccine combination with Sintilimab. Cohort 2: subjects will receive neoantigen tumor vaccine combination with Sintilimab and chemotherapy .
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen Personalized Cancer Vaccine | Experimental | Cohort 1: Salvage Therapy ; Cohort 2: Adjuvant Therapy Receives: Biological: Neoantigen Personalized Cancer Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as graded by CTCAE v5.0
Measured: Up to 2.5 years
Serious adverse events as graded by CTCAE v5.0
Measured: Up to 2.5 years
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Measured: Up to 2.5 years
Secondary outcomes (7)
Cohort 1: Objective Response Rate (ORR) by RECIST 1.1
Measured: Up to 2.5 years
Cohort 1: Duration of Response (DOR)
Measured: Up to 2.5 years
Cohort 1: Disease Control Rate (DCR)
Measured: Up to 2.5 years
Cohort 1: Progression Free Survival (PFS) as assessed by RECIST 1.1
Measured: Up to 2.5 years
Cohort 1: Overall Survival (OS)
Measured: Up to 2.5 years
Cohort 2: 18-month Recurrence-free survival (RFS) rate
Measured: Up to 2.5 years
Cohort 2: 18-month Overall Survival (OS) rate
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant TherapyStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- deepGeneAI, Bio-X Institutes, Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Hao Li, Ruijin Hospital
- Investigators
- Hao Li, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067385
- Sponsor's protocol ID
- JZ202401
- Acronym
- PCV-GSTT
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators decide not to share.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Neoantigen Tumor Vaccine Therapy for Gastrointestinal Solid Tumors
- ClinicalTrials.gov ID
- NCT07067385
- Acronym / sponsor ID
- PCV-GSTT / JZ202401
- Conditions
- Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy, Gastrointestinal Tumors
- Keywords
- neoantigen, p-MHC-TCR, CRC, mRNA, machine learning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- deepGeneAI, Bio-X Institutes, Shanghai Jiao Tong University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 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 efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors
Detailed description
This is a single-center, open, single-arm exploratory clinical study to evaluate the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors, and to provide more clinical treatment options for gastrointestinal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoantigen Personalized Cancer Vaccine | Experimental | Biological: Neoantigen Personalized Cancer VaccineCohort 1: Salvage Therapy ; Cohort 2: Adjuvant Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntarily signs the informed consent form, and has good compliance.
- Male or female, aged 18 years or older.
- Patients with advanced gastrointestinal tumors: histologically and/or cytologically confirmed recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment.
- Patients with resectable gastrointestinal solid tumors for adjuvant treatment: tumors must be confirmed as completely resected (R0 or R1) by postoperative histopathology, with no prior neoadjuvant therapy, and assessed as fully resectable by imaging.
- Neoantigen load requirement: at least 10 predicted neoantigen epitopes.
Key exclusion criteria (37 listed)
- Known allergy or hypersensitivity to any investigational drug or its components used in this study.
- Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.
- Receipt of the following therapies or interventions within 28 days before the first dose of study drug:
- Presence of severe chronic or active infection within 28 days before the first dose, including but not limited to hospitalization due to infection, sepsis, or severe pneumonia, or any active infection deemed to compromise patient safety by the investigator. Systemic antibiotic treatment within 2 weeks before study start.
- Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.
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 Personalized Cancer VaccineAlso: deepGeneAI-001Cohort 1: subjects will receive neoantigen tumor vaccine combination with Sintilimab. Cohort 2: subjects will receive neoantigen tumor vaccine combination with Sintilimab and chemotherapy . | Biological | Neoantigen Personalized Cancer Vaccine |
Primary outcome
Adverse events as graded by CTCAE v5.0
Time frame: Up to 2.5 years
Serious adverse events as graded by CTCAE v5.0
Time frame: Up to 2.5 years
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Time frame: Up to 2.5 years
7 secondary outcomes
Cohort 1: Objective Response Rate (ORR) by RECIST 1.1
Time frame: Up to 2.5 years
Cohort 1: Duration of Response (DOR)
Time frame: Up to 2.5 years
Cohort 1: Disease Control Rate (DCR)
Time frame: Up to 2.5 years
Cohort 1: Progression Free Survival (PFS) as assessed by RECIST 1.1
Time frame: Up to 2.5 years
Cohort 1: Overall Survival (OS)
Time frame: Up to 2.5 years
Cohort 2: 18-month Recurrence-free survival (RFS) rate
Time frame: Up to 2.5 years
Cohort 2: 18-month Overall Survival (OS) rate
Time frame: Up to 2.5 years
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 16 Jul 2025.
- Individual participant dataSharing planned: No. The investigators decide not to share.
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.
Hao Li principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neoantigen Personalized Cancer Vaccine in people with Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy and Gastrointestinal Tumors, run by Ruijin Hospital at 1 site 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 14 inclusion and 37 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hao Li, MD, PhD (86-15000660260, lh11001@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events as graded by CTCAE v5.0 (time frame: Up to 2.5 years). The study lists 3 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 16 Jul 2025.