Experimental vaccine fights sarcoma with Patient's own immune cells

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent. 2. Age≥18 years old, and≤70 years old ; 3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ; 4. Patients with first-line treatment failure ; 5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ; 6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ; 7. The following three screening indicators should be met in the test screening period: （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression. ( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators : 1. White blood cell count ≥ 3.0 × 109 / L; 2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ; 3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L; 4. platelet ( PLT ) ≥ 75 × 109 / L; 5. hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ; 6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; 7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; 8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min; 9. Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN; 10. Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN; 11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management. Exclusion Criteria: * 1\. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent. 2\. Age≥18 years old, and≤70 years old ; 3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ; 4. Patients with first-line treatment failure ; 5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ; 6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ; 7. The following three screening indicators should be met in the test screening period: （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression. ( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators : 1. White blood cell count ≥ 3.0 × 109 / L; 2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ; 3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L; 4. platelet ( PLT ) ≥ 75 × 109 / L; 5. hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ; 6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; 7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; 8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min; 9. Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN; 10. Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN; 11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.