Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors

Launched by THE FIRST AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Feb 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced malignant solid tumors, which are types of cancer that cannot be surgically removed. The researchers are testing a personalized vaccine made from specific proteins found in the tumor, called neoantigens. This vaccine aims to help the immune system recognize and fight the cancer more effectively. The study will monitor how well the treatment reduces tumor size, how the immune system responds, and whether it helps patients live longer.

To participate in this trial, patients must have inoperable advanced solid tumors, such as melanoma, breast, or lung cancer, and should have already tried standard treatments without success. Participants need to be at least 18 years old and in reasonably good health, with an expected survival of at least three months. Additionally, they should not have certain medical conditions or recent treatments that could interfere with the study. If eligible, participants can expect close monitoring and care throughout their involvement in the trial, with the goal of finding a safer and more effective cancer treatment.

Gender

ALL

Eligibility criteria

• 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