Actively Recruiting
Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based on Tumor Neoantigens, for Adjuvant Treatment in Patients With Biliary Malignant Tumors After Radical Resection
Led by Yifan Wang · Updated on 2026-02-03
20
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
Y
Yifan Wang
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the safety of iNeo-Vac-R01, an individualized mRNA therapeutic technology based on tumor neoantigens, for the adjuvant treatment of patients with biliary malignant tumors after radical resection.
CONDITIONS
Official Title
Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based on Tumor Neoantigens, for Adjuvant Treatment in Patients With Biliary Malignant Tumors After Radical Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Biliary malignant tumors confirmed by histopathological or cytological examination eligible for radical resection
- Advanced digestive system neoplasms with measurable disease by RECIST v1.1 and tumor progression after standard treatment or intolerance/unwillingness to receive standard treatment
- Toxic effects of previous anti-tumor treatments resolved to grade 1 or less
- Expected survival of 6 months or more
- ECOG performance status score of 0 to 1
- Availability of sufficient tumor tissue samples or original gene sequencing data for genetic analysis
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate organ function including neutrophil count, platelet count, hemoglobin, bilirubin, liver enzymes, albumin, creatinine, and coagulation parameters
- For women of childbearing potential, negative pregnancy test within 7 days prior to study and agreement to use contraception during treatment
- For men, agreement to use contraception during treatment
- Ability to comply with study protocol and follow-up
- Voluntary participation with signed informed consent
You will not qualify if you...
- Cancer requiring anti-tumor treatment within 5 years prior to enrollment, except certain early-stage or treated cancers
- Major surgery, traumatic injury, untreated wounds, or fractures within 2 weeks prior to first dose
- No new antigens found in sequencing data for individualized immunotherapy
- Planned or prior bone marrow or organ transplantation; anti-tumor treatments within 2 weeks prior to first dose
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first administration, except low-dose glucocorticoids
- Symptomatic or untreated central nervous system metastases unless stable for at least 4 weeks without need for glucocorticoids or anticonvulsants
- Receipt of other vaccines within 4 weeks before first dose or expected during treatment or 60 days after last dose
- Active or uncontrollable infections including tuberculosis
- Positive tests for hepatitis B or C, HIV, or syphilis
- Autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except specified exceptions
- Significant cardiocerebrovascular events or uncontrolled hypertension
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites or uncontrolled pleural or pericardial effusion
- Drug abuse or factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Investigator judgment of unsuitability or inability to complete study
- Vulnerable groups including mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yifan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here