DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma

Study Overview
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Brief Summary
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The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Official Title
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Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma: a Phase Ⅰ/Ⅱ Study

Conditions
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High-risk Soft Tissue Sarcoma

Intervention / Treatment
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* Biological: Adenovirus-transfected DC + CIK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intermediate or high grade sarcoma as determined by pathology review Histopathologically confirmed diagnosis of intermediate or high grade sarcoma Age≥18 years at time of consent KPS(Karnofsky Performance Scale) ≥70 Patient's written informed consent No steroid therapy within 4 weeks of first DC vaccination Stable disease, complete response and partial response(WHO, RECIST) Predicted survival≥3 months Normal liver, kidney and marrow function: WBC≥3.5×109/L、PLT≥90×109/L and Hb≥90g/L; blood Cr≤1.5×UNL (upper normal limit) and blood BIL≤1.5×UNL; ALT、AST≤1.5×UNL and ALT/AST≤5.0×UNL Exclusion Criteria: Serious dysfunction of vital organs(heart, liver or kidney) Received organ transplantation Patients with other malignancies or brain metastases History of autoimmune diseases Pregnant and breast-feeding patient Active or chronic infectious diseases History of allergy or hypersensitivity to study product excipients Currently participating in another clinical trial Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks Unfit for participating in this clinical trial in investigators' opinions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenovirus-transfected DC + CIK<br>Adenovirus-transfected autologous DCs + CIK cells | Biological: Adenovirus-transfected DC + CIK<br>* Adenovirus-transfected autologous DC vaccine plus CIK cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response (CR+PR) as measured by RECIST criteria |  | 4 weeks after DC/CIK treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 3 days within DC/CIK treatment |