CRC (Colorectal Cancer)Phase 1NCT07504484
Safety and Efficacy of Neoantigen-Based Personalized Immunotherapy as Consolidation Therapy After Standard Adjuvant Treatment in Resectable Stage III Colorectal Cancer or Non-Small Cell Lung Cancer
A Phase 1 study testing iNeo-Vac-P01 in people with CRC (Colorectal Cancer) and Non Small Lung Cancer, run by Ying Yuan, MD at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety, efficacy, and methodological feasibility of sequential administration of neoantigen-based personalized immunotherapy following completion of standard adjuvant therapy in patients with colorectal cancer or non-small cell lung cancer who have undergone… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CRC (Colorectal Cancer), Non Small Lung Cancer
- What is being tested?
- iNeo-Vac-P01
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 31 Dec 2023
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years;
- Voluntarily signed written informed consent;
- Agreed to provide tumor tissue and whole blood for sequencing; or able to supply raw gene sequencing data required for tumor neoantigen analysis and design of personalized anti-tumor neoantigen injection, including whole-exome sequencing data of tumor tissue, transcriptome sequencing data, and whole-exome sequencing data of peripheral blood;
- Patients with pathologically confirmed, clinically diagnosed Stage III resectable colorectal cancer or non-small cell lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Underwent radical resection of lesions;
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- Received postoperative adjuvant therapy in accordance with standard guideline-recommended regimens, completed the full guideline-recommended treatment cycles, and no new lesions were detected on imaging examinations;
- Complete imaging records must be available within 1 week prior to initiation of personalized immunotherapy, including but not limited to whole-body PET-CT and brain MRI. If whole-body PET-CT is not feasible, chest CT, contrast-enhanced abdominal CT, or bone ECT is required;
- Adequate organ and bone marrow function:
- White blood cell count ≥ 3,500/mcL
- Absolute lymphocyte count > 800/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelet count > 100,000/mcL
- Hemoglobin > 10.0 g/dL
- Total serum bilirubin < 1.5 × upper limit of normal (ULN)
- AST/ALT < 2.0 × ULN
- Serum creatinine < 1.5 × ULN
- For pregnant or lactating women: female subjects of childbearing potential must have a negative pregnancy test within 7 days before enrollment, have no childbearing plan in the near term, and be willing to use effective contraceptive measures (contraception or other birth control methods) before and during the study;
- Male patients willing to use appropriate contraceptive measures;
- Able to comply with the study protocol and follow-up procedures.
Who cannot join
- Poor general condition unsuitable for surgery or postoperative adjuvant therapy;
- New lesions detected on imaging after completion of postoperative adjuvant therapy;
- Received immunotherapy or other investigational medicinal products prior to surgery;
- Presence of other malignancies, except for cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia, etc., and those who have been disease-free for more than 5 years and are considered at low risk of recurrence by the investigator;
- No actionable neoantigens identified for personalized immunotherapy after analysis of sequencing data;
- Prior history of bone marrow transplantation or stem cell transplantation;
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- Concomitant use of any other anti-tumor drugs, anti-tumor therapies in other clinical trials, immunosuppressive agents, or long-term systemic glucocorticoids;
- Received any other vaccination within 4 weeks before treatment; Infection with HIV, HCV, or HBV; severe asthma; autoimmune disease or immunodeficiency; or immunosuppressed status (excluding vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormonal therapy, and psoriasis not requiring systemic treatment);
- Uncontrolled comorbidities including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
- Herpes virus infection (except those with scab formation for more than 4 weeks);
- Respiratory viral infection (except those recovered for more than 4 weeks);
- Severe coronary artery disease or cerebrovascular disease, or other diseases deemed ineligible by the investigator;
- Drug abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study;
- History of severe allergy to food, drugs, or vaccines, or potential allergy to immunotherapy as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
Official title: A Clinical Study on the Safety and Efficacy of Personalized Immunotherapy Based on Neoantigens as Consolidation Therapy Following Standard Postoperative Adjuvant Treatment in Patients With Stage III Resectable Colorectal Cancer or Non-Small Cell Lung Cancer
The primary objective of this study is to evaluate the safety, efficacy, and methodological feasibility of sequential administration of neoantigen-based personalized immunotherapy following completion of standard adjuvant therapy in patients with colorectal cancer or non-small cell lung cancer who have undergone radical resection.
Based on previous safety clinical trial results of personalized anti-tumor neoantigen injections, the 300 μg/peptide dose is well tolerated.
Therefore, this study will assess the safety and preliminary efficacy of personalized anti-tumor neoantigen injections at a dose of 300 μg/peptide as consolidation therapy after standard postoperative adjuvant treatment in patients with stage III resectable colorectal cancer or non-small cell lung cancer, aiming to provide novel personalized therapeutic strategies to improve disease-free survival (DFS) and overall survival (OS) in these patients.
- Conditions
- CRC (Colorectal Cancer), Non Small Lung Cancer
- Being tested
- iNeo-Vac-P01
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNeo-Vac-P01Biological
iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy.
For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows:
Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen).
Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| iNeo-Vac-P01 Group | Experimental | iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy.
For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows:
Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen).
Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit. Receives: Biological: iNeo-Vac-P01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Parameters:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of patients with clinical or laboratory adverse events (AEs) will be evaluated over a 7-month assessment period.
Assessment items include: vital signs, complete blood count, urinalysis, serum electrolytes, liver function, renal function, coagulation function, cytokines, and C-reactive protein (CRP).
Measured: 7 months
1-Year Recurrence-Free Survival Rate
Assessment method:
Contrast-enhanced CT/MRI imaging:
Every 2 months for the first 12 months; Every 3 months for the subsequent 12 months. If disease progression is determined according to RECIST v1.1 criteria, the clinician will decide whether to continue treatment based on whether the patient's clinical symptoms have improved and whether clinical benefit is achieved.
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 posted31 Mar 2026
- Study start30 Oct 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ying Yuan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Responsible party
- Sponsor-investigator, Ying Yuan, MD, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504484
- Sponsor's protocol ID
- 2020-656
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Personalized Immunotherapy Based on Neoantigens as Consolidation Therapy Following Standard Postoperative Adjuvant Treatment in Patients With Stage III Resectable Colorectal Cancer or Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07504484
- Acronym / sponsor ID
- 2020-656
- Conditions
- CRC (Colorectal Cancer), Non Small Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ying Yuan, MDUniversity, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Mar 2026 (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.
The primary objective of this study is to evaluate the safety, efficacy, and methodological feasibility of sequential administration of neoantigen-based personalized immunotherapy following completion of standard adjuvant therapy in patients with colorectal cancer or non-small cell lung cancer who have undergone radical resection.
Based on previous safety clinical trial results of personalized anti-tumor neoantigen injections, the 300 μg/peptide dose is well tolerated.
Therefore, this study will assess the safety and preliminary efficacy of personalized anti-tumor neoantigen injections at a dose of 300 μg/peptide as consolidation therapy after standard postoperative adjuvant treatment in patients with stage III resectable colorectal cancer or non-small cell lung cancer, aiming to provide novel personalized therapeutic strategies to improve disease-free survival (DFS) and overall survival (OS) in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNeo-Vac-P01 Group | Experimental | Biological: iNeo-Vac-P01iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy. For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows: Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen). Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years and ≤ 80 years;
- Voluntarily signed written informed consent;
- Agreed to provide tumor tissue and whole blood for sequencing; or able to supply raw gene sequencing data required for tumor neoantigen analysis and design of personalized anti-tumor neoantigen injection, including whole-exome sequencing data of tumor tissue, transcriptome sequencing data, and whole-exome sequencing data of peripheral blood;
- Patients with pathologically confirmed, clinically diagnosed Stage III resectable colorectal cancer or non-small cell lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Key exclusion criteria (14 listed)
- Poor general condition unsuitable for surgery or postoperative adjuvant therapy;
- New lesions detected on imaging after completion of postoperative adjuvant therapy;
- Received immunotherapy or other investigational medicinal products prior to surgery;
- Presence of other malignancies, except for cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia, etc., and those who have been disease-free for more than 5 years and are considered at low risk of recurrence by the investigator;
- No actionable neoantigens identified for personalized immunotherapy after analysis of sequencing data;
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 |
|---|---|---|
| iNeo-Vac-P01iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy. For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows: Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen). Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit. | Biological | iNeo-Vac-P01 Group |
Primary outcome
Safety and Tolerability Parameters:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 7 months
Number of patients with clinical or laboratory adverse events (AEs) will be evaluated over a 7-month assessment period. Assessment items include: vital signs, complete blood count, urinalysis, serum electrolytes, liver function, renal function, coagulation function, cytokines, and C-reactive protein (CRP).
1-Year Recurrence-Free Survival Rate
Time frame: 1 year
Assessment method: Contrast-enhanced CT/MRI imaging: Every 2 months for the first 12 months; Every 3 months for the subsequent 12 months. If disease progression is determined according to RECIST v1.1 criteria, the clinician will decide whether to continue treatment based on whether the patient's clinical symptoms have improved and whether clinical benefit is achieved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 iNeo-Vac-P01 in people with CRC (Colorectal Cancer) and Non Small Lung Cancer, run by Ying Yuan, MD 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 20 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: finished, as of the sponsor's last update on 31 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Parameters:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 7 months). 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 31 Mar 2026.