NCT02632006UnknownPhase 1
A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Programmed Death 1 (PD-1) in Treating Patients With Advanced Hepatocellular Carcinoma
Second Military Medical University1 site in 1 country40 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
Objectives:
The purpose of this study is to evaluate the safety and efficacy of PIK-PD-1 Cells in the treatment of advanced Hepatocellular Carcinoma.
Methods:
This study designs a novel therapy using PIK-PD-1 cells. 40 patients with advanced Hepatocellular Carcinoma will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-PD-1 cells group. Both DC-PMAT treatment and PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
Detailed Description
A total of 40 patients may be enrolled over a period of 1-2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 20~70 years old, male or female;
- •Barcelona Clinic Liver Cancer(BCLC) C stage; no indication for operation, local treatment (Transcatheter Arterial Chemoembolization (TACE), percutaneous icro wave coagulation therapy (PMCT), percutaneous ethanol injection therapy (PEIT)) and radiation therapy; unable or unwilling to receive sorafenib therapy; 3.Child-Pugh score ≤ 9; 4.Eastern Cooperative Oncology Group (ECOG) score ≤ 2; 5.Life expectancy>3 months;
- •white blood cell (WBC) > 3 x 10*9/L, Neutrophils > 1 x 10*9/L, lymphocyte > 1 x 10*9/L, hemoglobin ≥8.5g/dl, Platelet ≥50×109/L, prothrombin time (PT) no more than 3 seconds, Cr and blood urea nitrogen (BUN) less than 3 times of the normal level;
- •Adequate venous access, blood cell production without other taboos;
- •Signed informed consent.
Exclusion Criteria
- •Immunosuppressive therapy needed with autoimmune disease or organ transplantation history；
- •HIV/Syphilis infection;
- •Positive blood culture or imaging evidence infection;
- •Other drugs, gene therapy, biological, chemotherapy or radiation therapy were used within 1 months.
- •The history of allergic reactions in cell therapy or cytokine.
- •PD-1 antibodies have been used before, or allergies due to PD-1 antibody drugs.
- •History of interstitial lung disease.
- •History of esophagus varicosis rupture haemorrhage.
- •Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.
- •Pregnant, lactating women, or pregnancy planned at the following 2 years.
- •Without signed informed consent.
- •Other researchers considered ones unsuitable for inclusion.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 2 yeas
Secondary Outcomes
- Progress-free survival(2 yeas)
- Quality of life(2 yeas)
Investigators
Study Sites (1)
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