Actively Recruiting
Clinical Study to Assess Safety and Feasibility of Personalized mRNA Vaccine iNeo-Vac-R01 with Standard Adjuvant Therapy in Patients with Resected Digestive System Neoplasms
Led by Sir Run Run Shaw Hospital · Updated on 2023-09-11
20
Participants Needed
1
Research Sites
17 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
Researchers are evaluating the safety, feasibility, and effectiveness of a personalized mRNA vaccine called iNeo-Vac-R01 combined with standard adjuvant therapy in people who have had surgery to remove digestive system cancers. This Phase 1 clinical trial focuses on subjects with surgically resected digestive system neoplasms, including cancers such as cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, and colorectal carcinoma. Participants will first receive at least four cycles of standard adjuvant therapy following surgery, based on clinical guidelines. Then, they will receive the personalized mRNA vaccine iNeo-Vac-R01 through intramuscular injections on the first day of each 21-day cycle for up to nine cycles. The vaccine dose is determined during an earlier dose escalation phase of the study. Throughout the study, participants will undergo assessments including monitoring for adverse events up to 21 days after the last vaccine dose. Researchers will also evaluate overall survival, recurrence-free survival, immune responses involving T cells and cytokines, and the absence of disease recurrence at 12 and 24 months after the first vaccine dose. The total follow-up period for key outcomes extends up to three years after starting the vaccine treatment.
CONDITIONS
Brief 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
- Ability to understand and provide signed informed consent and comply with protocol
- Histologically or cytologically confirmed advanced digestive system neoplasm that can be surgically removed
- Ability to receive at least 4 cycles of standard adjuvant therapy after surgery
- Toxic effects of previous anti-cancer treatments recovered to grade 1 or less
- Expected survival of 6 months or more
- ECOG performance status score of 0 or 1
- Sufficient tumor tissue available for genetic analysis (at least 0.5cm x 0.5cm)
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate organ function including specific blood counts, liver and kidney function, and coagulation parameters
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during treatment
- Men must agree to use contraception or remain abstinent during treatment
You will not qualify if you...
- Cancer requiring anti-tumor treatment within 5 years before enrollment, except certain early-stage cancers
- Major surgery, traumatic injury, or untreated wounds/fractures within 2 weeks before first vaccine dose
- No new antigens found for personalized immunotherapy based on sequencing data
- Prior or planned bone marrow or organ transplantation
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first dose, except low doses
- Receipt of other vaccines within 4 weeks before first dose or planned during treatment and 60 days after last dose
- Active or uncontrolled infections requiring systemic treatment
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis beyond normal ranges
- Autoimmune diseases requiring immunosuppressive treatment or known primary immunodeficiency
- Significant heart or cerebrovascular diseases or severe ECG abnormalities
- Severe lung diseases or impaired lung function
- Moderate to severe ascites or uncontrolled pleural or pericardial effusions
- Drug abuse or factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Considered unsuitable for the trial by investigators
- Vulnerable groups including those with mental illness, cognitive impairment, critical illness, minors, pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months (9 cycles of 21 days each plus at least 4 cycles of adjuvant therapy)
Participants receive at least 4 cycles of standard adjuvant therapy after surgery followed by personalized mRNA vaccine iNeo-Vac-R01 via intramuscular injection on Day 1 of each 21-day cycle for up to 9 cycles.
Up to 13 visits every 21 days (1 visit per cycle)
Duration - Up to 3 years after first dose of iNeo-Vac-R01
Participants are monitored for safety, survival, disease recurrence, and immune response after completing treatment.
Periodic visits over 3 years for assessments
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
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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