Personalized neoantigen vaccine treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study provides a personalized tumor neoantigen peptide vaccine and neoantigen-based dendritic cell treatment for patients with advanced malignant solid tumors. It involves collecting blood samples for sequencing and bioinformatics analysis to identify neoantigens specific to each patient. Participants will receive 5-6 subcutaneous injections over a 14-week treatment period, followed by three follow-up visits to monitor tumor burden and immune response. The aim is to evaluate the effectiveness and safety of this personalized immunotherapy approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.
* Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment
* Had disease progression prior to treatment
* Expected survival ≥ 3 months
* ECOG performance status of 0, 1, or 2
* With a negative pregnancy test for females of childbearing age
* Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study
* Not positive for HIV, HBV, HCV, or TP
* ALT/AST ≤ 2.5 times the upper limit of normal
* ALP ≤ 2.5 times the upper limit of normal
* Serum creatinine ≤1.6 mg/dL
* Total bilirubin ≤ 1.5 mg/dL
* In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes \> 20%, absolute neutrophil count ≥ 1x10\^9/L, white blood cell count ≥ 3x10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin \> 8.0 g/dL, CD4+ cell count \> 200/μL
* With normal coagulation test and ECG
* Able to understand and willing to sign a written informed consent form

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with brain metastases
* Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months
* Participated in other clinical study within 30 days
* With severe allergies or histories of severe allergy
* With splenectomy
* With primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)
* Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroids
* With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability
* With a history of chronic alcohol or drug abuse within 6 months
* With unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)
* With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)
* Those the researcher believed inappropriate to participate in this study

Where it's running

• First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Sujun Li, PhD
• Email: 17600699826@163.com
• Phone: 8617600699826

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.