Actively Recruiting
Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Second-line Therapy for Colorectal Cancer Progressed After First-line Treatment A Multicenter Clinical Study
Led by The First Affiliated Hospital of Nanchang University · Updated on 2024-12-30
10
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with colorectal cancer (CRC) who have experienced disease progression after first-line therapy. The study aims to assess the effectiveness and safety of a personalized tumor neoantigen-based peptide vaccine together with conventional second-line therapy. Key outcomes observed include objective response rate (ORR), disease control rate (DCR), adverse events, progression-free survival (PFS), and overall survival (OS). The treatment plan includes conventional second-line therapies such as chemotherapy, targeted cancer drugs, and PD-1 inhibitors, with dosages and cycles determined by each patient's physician. Alongside, participants receive a personalized neoantigen-based peptide vaccine in two phases: a primary phase of 6 injections spaced weekly and biweekly, followed by a boost phase of 4 injections spaced three weeks apart. The full vaccine treatment spans 21 weeks, administered by subcutaneous injection. During the study, participants will undergo regular follow-up visits every 6 weeks after treatment completion. These visits include blood collection, physical exams, performance status assessments, imaging scans (CT/MRI, X-ray), lab tests, and any other necessary evaluations. Researchers will monitor treatment responses, disease control, and safety outcomes over an average of 30 weeks, ensuring close observation of participants' health and treatment effects throughout the study.
CONDITIONS
Official Title
Neoantigen-based Peptide Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed colorectal cancer
- At least one measurable lesion
- Aged 18 to 70 years, any gender
- Disease progression after standard first-line therapy, with more than 2 weeks since last antitumor treatment
- Expected survival of 3 months or more
- ECOG performance status of 0 or 1
- Female patients of childbearing age must have a negative pregnancy test and use effective contraception with no plans for pregnancy within 6 months
- Able to complete all required laboratory tests during screening
- Normal major organ function including heart, liver, and kidney
- Blood counts and liver/kidney function within specified limits
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Inflammatory markers and thyroid function tests within normal ranges
- Ability to understand and sign informed consent
You will not qualify if you...
- Uncontrollable brain metastases
- Expected to need any antitumor treatment during the study, including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroid or immunosuppressant use within 14 days before first dose (inhaled or topical allowed if no active autoimmune disease)
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in other clinical trials with first dose less than 4 weeks after last dose
- Severe cardiovascular diseases within specified recent timeframes
- Uncontrolled myocardial ischemia, arrhythmias, or hypertension
- Significant bleeding or bleeding tendency within 3 months before first dose
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infections within 4 weeks before first dose
- History of tissue/organ transplantation
- Uncontrolled epilepsy, CNS disorders, or cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergy history or atopic constitution
- History of chronic alcohol or drug abuse within 6 months
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
2
The First Hospital of Nanchang
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
Y
Yong Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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