Actively Recruiting
Neoantigen-based Peptide Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment
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
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
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
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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
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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