Actively Recruiting
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Led by Sir Run Run Shaw Hospital · Updated on 2023-09-11
20
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.
CONDITIONS
Official Title
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years able to understand and provide informed consent and comply with the study
- Histologically or cytologically confirmed advanced digestive system cancer with measurable disease by RECIST v1.1
- Tumor progression after standard treatment or intolerant/unwilling to receive standard treatment
- Toxic effects of previous treatments returned to grade 1 or specified levels
- Expected survival of 6 months or more
- ECOG performance status score between 0 and 2
- Sufficient tumor tissue samples or original gene sequencing data available for genetic analysis
- Echocardiographic left ventricular ejection fraction (LVEF) of 50% or higher
- Organ function meeting specified blood counts, liver and kidney function, and coagulation parameters
- Women of childbearing potential with negative pregnancy test and agreement to use contraception during treatment
- Men agreeing to use contraception during treatment
You will not qualify if you...
- Cancer requiring anti-tumor treatment within 5 years before enrollment except for certain early-stage cancers
- Major surgery, traumatic injury, or untreated wounds/fractures within 2 weeks before first vaccine dose
- No new antigens available for individualized immunotherapy based on sequencing data
- Previous or planned bone marrow or organ transplantation
- Other anti-tumor treatments within 2 weeks before first vaccine dose
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first dose beyond specified low doses
- Symptomatic or untreated central nervous system metastases not stable for at least 4 weeks
- Other vaccines within 4 weeks before first dose or planned within 60 days after last dose
- Active or uncontrolled infections including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis above normal ranges
- Autoimmune diseases or immune deficiencies treated with immunosuppressive drugs except specific exceptions
- Significant cardiocerebrovascular diseases or poorly controlled hypertension
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites or uncontrolled pleural/pericardial effusion
- Drug abuse or factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Investigator-determined unsuitability for enrollment or study completion
- 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
X
Xiujun Cai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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