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 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.

Study Overview

• Status: Completed
• Conditions: CRC (Colorectal Cancer); Non Small Lung Cancer
• Intervention / Treatment: Biological: iNeo-Vac-P01

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years;
2. Voluntarily signed written informed consent;
3. 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;
4. Patients with pathologically confirmed, clinically diagnosed Stage III resectable colorectal cancer or non-small cell lung cancer;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
6. Underwent radical resection of lesions;
7. 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;
8. 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;

9. 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
10. 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;
11. Male patients willing to use appropriate contraceptive measures;
12. Able to comply with the study protocol and follow-up procedures.

Exclusion Criteria:

1. Poor general condition unsuitable for surgery or postoperative adjuvant therapy;
2. New lesions detected on imaging after completion of postoperative adjuvant therapy;
3. Received immunotherapy or other investigational medicinal products prior to surgery;
4. 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;
5. No actionable neoantigens identified for personalized immunotherapy after analysis of sequencing data;
6. Prior history of bone marrow transplantation or stem cell transplantation;
7. Concomitant use of any other anti-tumor drugs, anti-tumor therapies in other clinical trials, immunosuppressive agents, or long-term systemic glucocorticoids;
8. 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);
9. Uncontrolled comorbidities including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
10. Herpes virus infection (except those with scab formation for more than 4 weeks);
11. Respiratory viral infection (except those recovered for more than 4 weeks);
12. Severe coronary artery disease or cerebrovascular disease, or other diseases deemed ineligible by the investigator;
13. Drug abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study;
14. History of severe allergy to food, drugs, or vaccines, or potential allergy to immunotherapy as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iNeo-Vac-P01 Group; 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.

Biological: iNeo-Vac-P01; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	1 year

Collaborators and Investigators

• Sponsor: Ying Yuan, MD
• Collaborators: Hangzhou Neoantigen Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2020-656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No