Actively Recruiting
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected 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 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
CONDITIONS
Official Title
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected 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 protocol
- Histologically or cytologically confirmed advanced digestive system neoplasms (cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, colorectal carcinoma) eligible for radical surgery
- Ability to receive at least 4 cycles of standard adjuvant therapy after surgery as per guidelines
- Previous anti-tumor treatment toxicities resolved to grade 1 or as specified
- Expected survival of 6 months or more
- ECOG performance status score of 0 to 1
- Sufficient tumor tissue sample available for genetic analysis (minimum 0.5cm x 0.5cm)
- Echocardiographic left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate organ function including specified blood counts, liver and kidney function, and coagulation parameters
- Negative pregnancy test within 7 days prior to study start for women of childbearing potential and agreement to use contraception or abstain during treatment
- Agreement for men to use contraception or abstain during treatment
You will not qualify if you...
- History of cancer requiring anti-tumor treatment within 5 years prior to enrollment, except certain treated early-stage cancers
- Major surgery, severe injury, or untreated wounds/fractures within 2 weeks prior to first vaccine dose
- No new antigens available for individualized immunotherapy based on sequencing data
- Planned or previous bone marrow or organ transplantation, or other anti-tumor treatments within 2 weeks before first vaccine dose
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first vaccine dose, except low-dose glucocorticoids
- Receipt of other vaccines within 4 weeks before first vaccine dose or expected vaccination during study or within 60 days post last dose
- Active or uncontrolled infections requiring systemic treatment, including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis beyond normal ranges
- Autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except certain controlled conditions
- Significant heart or cerebrovascular diseases or severe ECG abnormalities
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites, pleural or pericardial effusion
- Drug abuse or social/psychological factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Investigator judgment deeming subject unsuitable or unable to complete the study
- Vulnerable populations including mental illness, cognitive impairment, critical illness, 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
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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