Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001337268
Ethics application status
Approved
Date submitted
22/09/2017
Date registered
8/08/2018
Date last updated
8/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigate the safety and efficacy of small cell lung cancer,Kidney cancer and Primary liver cancer immunotherapy
Scientific title
The safety and efficacy of immunotherapy with the activited T cells from from umbilical cord blood mononuclear cells ex vivo for small cell lung cancer,Kidney cancer and Primary liver cancer treatment
Secondary ID [1] 292707 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histopathologically confirmed small cell lung cancer (SCLC) 304465 0
Histopathologically confirmed Kidney cancer 307605 0
Histopathologically confirmed Liver cancer 307606 0
Condition category
Condition code
Cancer 303804 303804 0 0
Lung - Small cell
Cancer 304050 304050 0 0
Kidney
Cancer 304051 304051 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
UCMCs are isolated from the Umbilical cord blood and seeded in serum-free medium at a concentration of 10(7) cells / mL. The cells are stimulated with different cytokines, including IFN-Gamma, CD-3 monoclonal antibody and PD-1, The cells are reconstituted with fresh, complete culture medium until the mature immune cells are harvested on day 14. The small cell lung,liver and kidney cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week at the same time. Treating clinician will be administering the intervention.The first single dose is initiated at 2X10(9) cells iv injection(Cell counting counter). If no side-effects, injection dosage increases to 10X10(9) on the second week, and escalates to 20x10(9) cells on the third week. The total injections are 3-6 times depending on the availability of tumour sample. The safety and effectiveness are investigated. For example, the phenotype (CD3, CD4, CD8, CD16, CD19, CD45RO and CD56), interferon-gamma,IL-2,IL-12,IL-17,IL-10,TGF-ß1 expression in the peripheral blood lymphocytes are measured before injection and one week after the third injection.
Intervention code [1] 298948 0
Treatment: Other
Comparator / control treatment
before and after treatment compare
Control group
Active

Outcomes
Primary outcome [1] 303175 0
Assess the safety of treatment from blood samples, questionnaires and medical records(Malignant tumor follow-up table,it was designed specifically for this study).
Timepoint [1] 303175 0
after injections of immune cell
Primary outcome [2] 306200 0
determine the size of a patient's tumor by PET-CT
Timepoint [2] 306200 0
three months after injections of immune cell
Secondary outcome [1] 338132 0
Effectiveness: 1. Survival time,based off of hospital follow-up records
Timepoint [1] 338132 0
Case follow-up: 3 years after immunotherapy.
Secondary outcome [2] 342855 0
The tumour-specific cytotoxicity will be measured by interferon-gamma ELISPOT( enzyme-linked immunospot assay)
Timepoint [2] 342855 0
before and after three injections of immune cell
Secondary outcome [3] 342856 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD45,CD3
Timepoint [3] 342856 0
before and 12 weeks after the third injection
Secondary outcome [4] 348675 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD3+CD4+
Timepoint [4] 348675 0
before and 12 weeks after three injections of immune cell
Secondary outcome [5] 348676 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD3+CD8+
Timepoint [5] 348676 0
before and 12 weeks after three injections of immune cell
Secondary outcome [6] 348677 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD19+
Timepoint [6] 348677 0
before and 12 weeks after three injections of immune cell
Secondary outcome [7] 348678 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD16+CD56+
Timepoint [7] 348678 0
before and 12 weeks after three injections of immune cell
Secondary outcome [8] 348679 0
The phenotype of the peripheral blood lymphocytes in the studied group will be analysed using flow cytometry: CD4/CD8
Timepoint [8] 348679 0
before and 12 weeks after three injections of immune cell
Secondary outcome [9] 348680 0
IFN-gamma in serum of patients.
Timepoint [9] 348680 0
before and 12 weeks after three injections of immune cell
Secondary outcome [10] 348681 0
IL-2 in serum of patients.
Timepoint [10] 348681 0
before and 12 weeks after three injections of immune cell
Secondary outcome [11] 348682 0
IL-10in serum of patients.
Timepoint [11] 348682 0
before and 12 weeks after three injections of immune cell
Secondary outcome [12] 348685 0
ß2-microglobulinand in serum of patients.
Timepoint [12] 348685 0
before and 12 weeks after three injections of immune cell
Secondary outcome [13] 348686 0
TGF-ß1 in serum of patients.
Timepoint [13] 348686 0
before and 12 weeks after three injections of immune cell
Secondary outcome [14] 348687 0
LDH in serum of patients.
Timepoint [14] 348687 0
before and 12 weeks after three injections of immune cell

Eligibility
Key inclusion criteria
(1) Histopathological diagnosis of SCLC,Kidney cancer and Primary liver cancer; (2) KPS (Karnofsky performance score, KPS) score> 60 points or more; (3) is expected to complete chemotherapy or survival of at least 4 months, did not accept other anti-tumor therapy.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) organ failure (heart function four, or liver function Child Pugh grading above grade C, brain metastases with disturbance of consciousness, or severe respiratory failure); (2) at the same time to accept other anti-tumor therapy (3) severe coagulation dysfunction; (4) patients with allergic to interleukin-2 or biologics; (5) a history of organ transplantation, the use of immunosuppressive agents or organ transplantation after long-term use of immunosuppressive agents; (6) patients with definite infection or unexplained fever (7) Pregnant and lactating women; (8) T lymphoma patients, infectious diseases, autoimmune diseases or other malignancies; (9) HIV-positive, drug addiction.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2018
Actual
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 9161 0
China
State/province [1] 9161 0

Funding & Sponsors
Funding source category [1] 297345 0
Hospital
Name [1] 297345 0
The First Teaching Hospital, Inner Mongolia Medical University
Country [1] 297345 0
China
Primary sponsor type
Hospital
Name
The First Teaching Hospital, Inner Mongolia Medical University
Address
The First Teaching Hospital, Tong Dao Beijian No.1, Hohhot, Inner Mongolia, 010050
Country
China
Secondary sponsor category [1] 296322 0
None
Name [1] 296322 0
Address [1] 296322 0
Country [1] 296322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298445 0
Ethics committee Affiliated Hospital of Inner Mongolia Medical University
Ethics committee address [1] 298445 0
Ethics committee country [1] 298445 0
China
Date submitted for ethics approval [1] 298445 0
06/03/2017
Approval date [1] 298445 0
02/05/2017
Ethics approval number [1] 298445 0

Summary
Brief summary
This clinical pilot study examines feasibility and outcome of the tumour specific treatment for patients with advanced small cell lung cancer, Kidney cancer and Primary liver cancer . Procedures: UCMCs are isolated from the Umbilical cord blood and stimulated with different cytokines. The cells are reconstituted with fresh, complete culture medium until the mature immune cells are harvested on day 14. The small cell lung, liver and kedney cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week. The safety and effectiveness are investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77118 0
Dr Sheng YUN
Address 77118 0
Department of Oncology, The First Teaching Hospital, Inner Mongolia Medical University, 1st of Tongdao Street,Hui District,Hohhot, Inner Mongolia, 010050
Country 77118 0
China
Phone 77118 0
+86 471 3451700
Fax 77118 0
+86 471 6965931
Email 77118 0
sheng.yun@hotmail.co.uk
Contact person for public queries
Name 77119 0
Dr Sheng YUN
Address 77119 0
Department of Oncology, The First Teaching Hospital, Inner Mongolia Medical University, 1st of Tongdao Street,Hui District,Hohhot, Inner Mongolia, 010050
Country 77119 0
China
Phone 77119 0
+ 86 15248158962
Fax 77119 0
+86 471 6965931
Email 77119 0
sheng.yun@hotmail.co.uk
Contact person for scientific queries
Name 77120 0
Dr Sheng YUN
Address 77120 0
Department of Oncology, The First Teaching Hospital, Inner Mongolia Medical University, 1st of Tongdao Street,Hui District,Hohhot, Inner Mongolia, 010050
Country 77120 0
China
Phone 77120 0
+86 15248158962
Fax 77120 0
+86 471 6965931
Email 77120 0
sheng.yun@hotmail.co.uk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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