Actively Recruiting
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment 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 in combination with first-line treatment in subjects with advanced digestive system neoplasms.
CONDITIONS
Official Title
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment 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 sign informed consent, and comply with study requirements
- Histologically or cytologically confirmed advanced digestive system neoplasms with measurable disease
- Received at least 4 cycles of standard first-line treatment as per guidelines
- Toxic effects of prior treatments recovered to grade 1 or acceptable level
- Expected survival of 6 months or more
- ECOG performance status of 0 or 1
- Available tumor tissue samples with sufficient tumor purity or original gene sequencing data for analysis
- Left ventricular ejection fraction of 50% or higher by echocardiography
- Organ function within specified limits including blood counts, liver and kidney function, and coagulation parameters
- Women of childbearing potential must have negative pregnancy test and agree to contraception during treatment
- Men must agree to contraception during treatment
You will not qualify if you...
- Cancer requiring anti-tumor treatment within 5 years prior to enrollment except 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
- History or planned bone marrow or organ transplantation
- Anti-tumor treatments within 2 weeks before first vaccine dose or during study
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first vaccine dose except low-dose steroids
- Symptomatic or untreated central nervous system metastases unless stable after treatment for at least 4 weeks
- Receipt of other vaccines within 4 weeks before first vaccine dose or expected during treatment or 60 days after last dose
- Active or uncontrolled infections including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Autoimmune diseases treated with immunosuppressive drugs except certain controlled conditions
- Recent or severe cardiocerebrovascular diseases or uncontrolled hypertension
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites or significant pleural or pericardial effusions
- Drug abuse or social/psychological factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Other reasons deemed unsuitable by investigators
- Vulnerable populations including mental illness, cognitive impairment, critical condition, minors, pregnant or breastfeeding 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
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