malignant solid tumor
Conditions
Interventions
Experimental group:inject personalized mRNA cancer vaccine
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender restriction, age 18 or above; 2. Subjects with unresectable or metastatic advanced malignant tumors confirmed by histology or cytology, including but not limited to renal cell carcinoma, bladder cancer and other urological malignant tumors, non-HPV-infected oral cancer, cholangiocarcinoma, etc. ; 3. Standard treatment fails or there is no standard treatment; 4. The physical fitness score in the ECOG scale is 0-1; 5. Expected survival period >= 6 months; 6. According to the definition of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, there are measurable lesions, if there are multiple lesions, up to 5 lesions (no more than 2 per organ); according to RECIST1.1, the subject is judged as Low progression status (defined as disease progression in limited anatomical sites, persistent reactivity, or stable disease elsewhere) or no threatening progression; 7. The time interval from the previous drug treatment, radiotherapy and surgical treatment is more than 3-4 weeks; oral fluorouracil and small molecule targeted drugs are required to exceed 2 weeks or within 5 half-lives of the drug (whichever is longer); 8. Laboratory inspections meet the following standards: Bone marrow function: absolute blood neutrophil count (ANC) >=1 x 10^9/L, hemoglobin >=8 g/dL platelet (PLT) >=75 x 10^9/L; Liver function: serum total bilirubin (STB), conjugated bilirubin (CB) =50 mL/min (calculated by Cockcroft-Gault formula); 9. Female subjects with reproductive potential need to use appropriate contraceptive measures during the study; 10 Subjects are willing and able to comply with the treatment regimen, including receiving treatment and regular follow-up; 11. Subjects agree to blood collection for research, and agree to use biopsy or surgically resected samples for vaccine preparation and related research; 12. The subject needs to recover from all reversible teratotoxic reactions of the previous cancer treatment regimen to <= grade 1 or baseline status; 13. Subjects voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject is currently participating in a clinical trial or within 4 weeks; 2. The subject has active infection and requires systemic treatment; 3. Pregnant and lactating women; 4. The subject is known to have other malignant tumors, which are active or progressive and require treatment; 5. The subject's symptomatic brain metastases are uncontrolled; 6. The subject is currently using a daily dose of >=10 mg prednisone or an equivalent dose of systemic corticosteroids, or other immunosuppressive drugs, including but not limited to methotrexate, azathioprine, calcineurin inhibitors and TNF-a receptor blockers; 7. The subject has HIV, HBV, HCV infection; 8. The subject suffers from severe autoimmune disease; 9. The subject has a history of organ transplantation, known bone marrow or hematopoietic stem cell transplantation; 10. Those with abnormal coagulation function; 11. Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, such as arrhythmia, congestive heart failure, or severe coronary artery disease within 30 days; 12. Those with mental disorders that are not under control; 13. Subjects were vaccinated with any form of vaccine within 28 days before administration; 14. Subjects deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;cytokine suite; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine;urine routine;biochemical suite;coagulation function;cardiac enzyme;tumor indicator;cardiac ultrasound;bone scan;Positron Emission Computed Tomography;Vital sign;Immune response monitoring; | — |
Countries
China
Contacts
Public ContactDong Chunyan
Shanghai East Hospital
Outcome results
None listed