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Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Primary Purpose

Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TACE
Precision Cells
Sponsored by
Shanghai International Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precision Cells focused on measuring Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18~65 years old, male or female;
  • Life expectancy≥6 months;
  • ECOG score: 0-3;
  • Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
  • Enough venous channel, no other contraindications to the separation and collection of white blood cells;
  • Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
  • Signed informed consent;
  • Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

  • Expected Overall survival < 3 months;
  • The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
  • Liver function is Childs Pugh C;
  • Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
  • Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
  • Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Sites / Locations

  • Shanghai International Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Precision Cells

Transcatheter Arterial Chemoembolization

Arm Description

Precision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells:After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment

patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Outcomes

Primary Outcome Measures

Overall survival
Progress-free survival

Secondary Outcome Measures

Quality of life
Questionnaire will be used.

Full Information

First Posted
August 8, 2016
Last Updated
September 1, 2016
Sponsor
Shanghai International Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02862613
Brief Title
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Official Title
Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai International Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.
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
Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer
Keywords
Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer

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
Precision Cells
Arm Type
Experimental
Arm Description
Precision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells:After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment
Arm Title
Transcatheter Arterial Chemoembolization
Arm Type
Active Comparator
Arm Description
patients will receive MMC,EADM hepatic arterial infusion,6 cycles.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
Lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg.According to tumor area of maximum diameter,0.1~0.2ml/cm2 Hepatic arterial infusion.
Intervention Type
Biological
Intervention Name(s)
Precision Cells
Intervention Description
DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 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 years
Title
Progress-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life
Description
Questionnaire will be used.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18~65 years old, male or female; Life expectancy≥6 months; ECOG score: 0-3; Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out; Enough venous channel, no other contraindications to the separation and collection of white blood cells; Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level; Signed informed consent; Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. Exclusion Criteria: Expected Overall survival < 3 months; The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus; Liver function is Childs Pugh C; Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney; Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naiyan Han
Phone
+86 21 6023 6666
Email
naiyan.han@simcgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiyan Han
Organizational Affiliation
Shanghai International Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai International Medical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201318
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiyan Han
Phone
+86 (0) 182 1766 2469
Email
naiyan.han@simcgroup.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

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