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New treatment option for Advanced Malignant Solid Tumors
Official title Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT05749627
What this study is testing
What is Neoantigen peptide vaccine?
Neoantigen peptide vaccine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced malignant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.
- Time commitment: about 14 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung...
- 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
You likely can't join if
- 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
See the full eligibility 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 \>...
- With normal coagulation test and ECG
- Able to understand and willing to sign a written informed consent form
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 14 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.