[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641897":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug delivery mode 1","EXPERIMENTAL","1. Neoantigen Vaccine Injection: Each subject receives injections of vaccine components determined from prior in vitro experiments throughout the treatment course. The SarcVac peptide vaccine, mixed with an adjuvant (PolyI:C) in 0.5 ml of saline, is administered subcutaneously in the inguinal region on days 1, 3, 7, 15, 30, 65, and 86 from treatment initiation.\n2. Tumor-Specific Lymphocyte Infusion: Throughout the treatment course, each subject receives tumor-specific lymphocyte infusions.\n3. Antibody Therapy: Subjects receive anti-PD-1 antibody (Sintilimab) via intravenous infusion throughout the treatment period.",[13],"Biological: Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody",{"label":15,"type":10,"description":16,"interventionNames":17},"Drug delivery mode 2","1. Neoantigen Vaccine Injection: Each subject receives injections of vaccine components determined from prior in vitro experiments throughout the treatment course. The SarcVac peptide vaccine, mixed with an adjuvant (PolyI:C) in 0.5 ml of saline, is administered subcutaneously in the inguinal region on days 1, 3, 7, 15, 30, 65, and 86 from treatment initiation.\n2. Antibody Therapy: Subjects receive anti-PD-1 antibody (Sintilimab) via intravenous infusion throughout the treatment period.",[18],"Biological: Neoantigen vaccine + anti-PD1 antibody",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody","Neoantigen vaccine+ specific lymphocytes + anti-PD1 antibody",[9],null,{"type":21,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Neoantigen vaccine + anti-PD1 antibody",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Zhang","CONTACT","86-020-87343192","zhangxing@sysucc.org.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Xing Zhang","Vice director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor","100641897","phase-1-tumor-neoantigen-vaccine-sarvac-combined-with-tumor-specific-lymphocyte-reinfusion-in-the-treatment-of-advanced-sarcoma-100641897",false,"NCT07648069","Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma","A Prospective, Single-center, Double-arm, Phase I Clinical Trial of Tumor Neoantigen Vaccine SarVac Combined With Tumor-specific Lymphocyte Reinfusion in the Treatment of Patients With Advanced or Unresectable Sarcoma-based Solid Tumors Who Failed Standard Treatment.","Inclusion Criteria:\n\n1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n2. Age≥18 years old, and≤70 years old ;\n3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;\n4. Patients with first-line treatment failure ;\n5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;\n6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ;\n7. The following three screening indicators should be met in the test screening period:\n\n（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.\n\n( 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 :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. 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.\n\nExclusion Criteria:\n\n* 1\\. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n\n  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:\n\n  （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.\n\n( 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 :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. 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.","ALL","18 Years","70 Years",{"count":67,"type":68},16,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.",[74,75],"Soft Tissue Sarcoma (STS)","Osteosarcoma","2026-06-12",{"date":78,"type":79},"2026-06-15","ACTUAL",{"date":81,"type":79},"2024-09-03",{"date":83,"type":68},"2027-06-30",{"name":5,"class":6},1]