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Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PIK-PD-1 cells

DC-PMAT

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring PIK-PD-1 Cells, dendritic cell-precision multiple antigen T cells, advanced hepatocellular carcinoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PIK-PD-1 cells

DC-PMAT

Arm Description

PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods.

DC-PMAT cells treatment will be performed every 3 weeks with a total of three periods.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progress-free survival

Quality of life

Quality of life core questionnaire will be used.

Full Information

NCT ID

NCT02632006

First Posted

December 13, 2015

Last Updated

December 30, 2015

Sponsor

Second Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02632006

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Military Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

Keywords

PIK-PD-1 Cells, dendritic cell-precision multiple antigen T cells, advanced hepatocellular carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PIK-PD-1 cells

Arm Type

Experimental

Arm Description

PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods.

Arm Title

DC-PMAT

Arm Type

Active Comparator

Arm Description

DC-PMAT cells treatment will be performed every 3 weeks with a total of three periods.

Intervention Type

Biological

Intervention Name(s)

PIK-PD-1 cells

Intervention Description

DC cell suspension (1×10*7 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-PD-1 cell suspension (1-6×10*9 PIK-PD-1 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Intervention Type

Biological

Intervention Name(s)

DC-PMAT

Intervention Description

DC cell suspension (1×10*7 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×10*9 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

2 yeas

Secondary Outcome Measure Information:

Title

Progress-free survival

Time Frame

2 yeas

Title

Quality of life

Description

Quality of life core questionnaire will be used.

Time Frame

2 yeas

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qijun Qian, PHD

Phone

+86-21-65580677

qianqj@sino-gene.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Huajun Jin, PHD

Phone

+86-21-81875372

hj-jin@Hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qijun Qian, PHD

Organizational Affiliation

Eastern Hepatobiliary Surgery Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Eastern Hepatobiliary Surgery Hospital

City

Shanghai

ZIP/Postal Code

200438

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huajun Jin, PHD

Phone

+86-21-81875372

hj-jin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Qijun Qian, PHD

First Name & Middle Initial & Last Name & Degree

Huajun Jin, PHD

First Name & Middle Initial & Last Name & Degree

Yao Huang, MD

First Name & Middle Initial & Last Name & Degree

Xijing Yang, MD

First Name & Middle Initial & Last Name & Degree

Saiqun Lv, PHD

12. IPD Sharing Statement

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Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma

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