Clinical trial NCT02632006: Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: PIK-PD-1 Cells
dendritic cell-precision multiple antigen T cells
advanced hepatocellular carcinoma
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1. Age 20\~70 years old, male or female; 2. 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; 6. 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; 7. Adequate venous access, blood cell production without other taboos; 8. Signed informed consent.

Exclusion Criteria:

* 1. Immunosuppressive therapy needed with autoimmune disease or organ transplantation history； 2. HIV/Syphilis infection; 3. Positive blood culture or imaging evidence infection; 4. Other drugs, gene therapy, biological, chemotherapy or radiation therapy were used within 1 months.

  5. The history of allergic reactions in cell therapy or cytokine. 6. PD-1 antibodies have been used before, or allergies due to PD-1 antibody drugs.

  7. History of interstitial lung disease. 8. History of esophagus varicosis rupture haemorrhage. 9. Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.

  10. Pregnant, lactating women, or pregnancy planned at the following 2 years. 11. Without signed informed consent. 12. Other researchers considered ones unsuitable for inclusion.

Primary outcomes:
measure: Overall survival
timeFrame: 2 yeas
Secondary outcomes:
measure: Progress-free survival
timeFrame: 2 yeas
measure: Quality of life
timeFrame: 2 yeas
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Qijun Qian, PHD
role: STUDY_CHAIR
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