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

December 30, 2015 updated by: Second Military Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A total of 40 patients may be enrolled over a period of 1-2 years.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Principal Investigator:
          • Qijun Qian, PHD
        • Principal Investigator:
          • Huajun Jin, PHD
        • Principal Investigator:
          • Yao Huang, MD
        • Sub-Investigator:
          • Xijing Yang, MD
        • Sub-Investigator:
          • Saiqun Lv, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIK-PD-1 cells
PIK-PD-1 cells treatment will be performed every 3 weeks with a total of three periods.
Biological: PIK-PD-1 cells

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 yeas
2 yeas

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival
Time Frame: 2 yeas
2 yeas
Quality of life
Time Frame: 2 yeas
Quality of life core questionnaire will be used.
2 yeas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Military Medical University

Investigators

  • Study Chair: Qijun Qian, PHD, Eastern Hepatobiliary Surgery Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2015-02-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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