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New treatment option for Soft Tissue Sarcoma (STS)
Official title Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
ClinicalTrials.gov ID: NCT07648069
What this study is testing
What is Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody?
Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody is an investigational medicine, being studied as a potential treatment for soft tissue sarcoma (sts).
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
- 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.
- Phase 1: an early, usually small safety study
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
- Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
- Age≥18 years old, and≤70 years old ;
- Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;
- Patients with first-line treatment failure ;
- No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;
You likely can't join if
- 1\. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent. 2\. Age≥18 years old...
- White blood cell count ≥ 3.0 × 109 / L;
- absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
- absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
- platelet ( PLT ) ≥ 75 × 109 / L;
- hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
See the full eligibility criteria
- Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
- Age≥18 years old, and≤70 years old ;
- Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;
- Patients with first-line treatment failure ;
- No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;
- According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ;
- 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...
- White blood cell count ≥ 3.0 × 109 / L;
- absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
- absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
- platelet ( PLT ) ≥ 75 × 109 / L;
- hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
- Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
- partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
- serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min;
- Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN;
- Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN;
- 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...
- 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...
- White blood cell count ≥ 3.0 × 109 / L;
- absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
- absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
- platelet ( PLT ) ≥ 75 × 109 / L;
- hemoglobin ≥ 90g / dL ( no blood transfusion in the past 7 days ) ;
- Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
- partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;
- serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min;
- Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN;
- Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Guangzhou, Guangdong, 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.