Actively Recruiting
Neoantigen-loaded DC 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-loaded DC 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-loaded DC 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 tumor lesion
- Age between 18 and 70 years
- Disease progression after standard first-line therapy and more than 2 weeks since last antitumor treatment
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Female patients of childbearing potential with a negative pregnancy test and use of effective contraception for 6 months
- Ability to complete all required screening laboratory tests
- Normal major organ function including heart, liver, and kidney
- Blood counts and chemistry within specified limits
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel results within specified ranges
- Thyroid function tests within specified ranges
- Adrenocorticotropic hormone levels within specified range
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Patients with uncontrollable brain metastases
- Patients expected to need other antitumor treatments during the study including maintenance or surgery
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressants within 14 days before first dose
- Treatment with anticancer immunotherapies or immunostimulatory drugs within 3 months before first dose
- Participation in another clinical trial with less than 4 weeks since last dose
- Severe cardiovascular diseases including recent myocardial infarction or unstable arrhythmias
- Uncontrolled hypertension not managed by medication
- Significant bleeding symptoms or tumors invading major blood vessels
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infections within 4 weeks before first dose
- Prior or planned tissue/organ transplantation
- Uncontrolled epilepsy or neurological disorders causing 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 making the patient unsuitable for the study as judged 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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