This trial is active, not recruiting.

Condition high-risk soft tissue sarcoma
Treatment adenovirus-transfected dc + cik
Phase phase 1/phase 2
Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Start date June 2013
End date December 2016
Trial size 30 participants
Trial identifier NCT01898663, 307-CTC-DC/CIK


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Adenovirus-transfected autologous DCs + CIK cells
adenovirus-transfected dc + cik
Adenovirus-transfected autologous DC vaccine plus CIK cells

Primary Outcomes

Objective tumor response (CR+PR) as measured by RECIST criteria
time frame: 4 weeks after DC/CIK treatment

Secondary Outcomes

Number of participants with adverse events
time frame: 3 days within DC/CIK treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Chen Hu, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Affiliated Hospital to Academy of Military Medical Sciences.