Actively Recruiting
Neoantigen-based Peptide Vaccine and Conventional Third-line Therapy for CRC Progressed After Second-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 third-line therapy to patients with colorectal cancer (CRC) progressed after second-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 Third-line Therapy for CRC Progressed After Second-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 between 18 and 70 years
- Disease progression after standard second-line therapy and 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 six months
- Ability to complete all required laboratory tests during the screening period
- Normal major organ function including heart, liver, and kidney
- Hematologic parameters within specified limits (neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine, blood urea nitrogen, clotting tests)
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel and thyroid function tests within specified ranges
- Adrenocorticotropic hormone levels within 1.1-17.6 pmol/L
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Uncontrollable brain metastases
- Need for any form of antitumor treatment during the study including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroid or immunosuppressant use within 14 days before first dose (inhalational or topical corticosteroids allowed if no active autoimmune disease)
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in other clinical trials within 4 weeks or 5 half-lives of previous study drug
- Severe cardiovascular diseases including recent myocardial infarction, cerebrovascular events, unstable arrhythmias, or unstable angina
- Uncontrolled hypertension despite medication
- Recent significant bleeding or bleeding tendency, tumors invading major blood vessels, or recent hemoptysis
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infections within 4 weeks before first dose
- History or preparation for tissue/organ transplantation
- Uncontrolled epilepsy, CNS disorders causing cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergies or atopic constitution
- History of chronic alcohol or drug abuse within 6 months
- Deemed unsuitable for study by 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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