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Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CIK combined with chemotherapy group
CIK combined immunotherapy group
CIK combined targeted therapy group
CIK in combination with other therapies
Sponsored by
ShiCang Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Autologous cytokine induced killer cells

Eligibility Criteria

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

Inclusion Criteria: Age range 18-70 years; Patients diagnosed with colorectal cancer, TNM stage III-IV; Had at least one extracranially measurable lesion by recist1.1 criteria; ④ Patients who had failed at least one or two prior lines of standard therapy or relapsed, or who were intolerant to or voluntarily abandoned one or two prior lines of standard therapy; ⑤ Expected survival ≥ 90 days; The major organs function normally; ⑦ The subject voluntarily joined this study, signed the informed consent, complied well and cooperated with the follow-up. Exclusion Criteria: Had participated in other clinical trialists of drugs within 4 weeks before the start of the study; Those who had hypertension that was inadequately controlled with a single antihypertensive agent (systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg, as judged by the investigator), had myocardial ischemia or myocardial infarction of grade I or higher, arrhythmia of grade I and higher (including QT interval ≥ 440 MS), or cardiac dysfunction; Those with a history of substance abuse who are unable to abstain or who have a history of mental disorders; Presence of fungal, bacterial, viral, or other infections that are not controllable or require antibiotic therapy; For subjects with prior chemotherapy use, ≥ grade 2 hematologic toxicity, or ≥ grade 3 nonhematologic toxicity according to nci-ctcae 5.0 criteria at enrollment; ⑥ Known presence of a history of HIV, or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) nucleic acid test positive; Presence of any indwelling catheter or drain (eg, biliary drain or pleural / peritoneal / pericardial catheter). Use of a dedicated central venous catheter was permitted (colostomy for patients with bowel cancer, percutaneous nephrostomy tube, indwelling Frey catheter, considered by the investigator for implications); ⑧ Presence of brain metastases, presence of a history or disease of the CNS such as seizure disorders, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;

Sites / Locations

  • Southwest Hospital, Army Medical University (Third Military Medical University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CIK combined with chemotherapy group

CIK combined immunotherapy group

CIK combined targeted therapy group

CIK in combination with other therapies

Arm Description

Combination of CIK cells and chemotherapy

Combination of CIK cells and immunotherapy

Combination of CIK cells and targeted therapy

CIK in combination with any two or three of these (i.e., chemotherapy, immunotherapy, and targeted therapy) treatments

Outcomes

Primary Outcome Measures

Disease control rate (DCR)
Disease control rate of colorectal cancer
objective response rate (ORR)
objective response rate of colorectal cancer

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
January 6, 2023
Sponsor
ShiCang Yu
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1. Study Identification

Unique Protocol Identification Number
NCT05676190
Brief Title
Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer
Official Title
Treatment of Colorectal Cancer With Autologous Cytokine Induced Killer Cells (CIK)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ShiCang Yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project plans to use CIK combined with chemotherapy, immunotherapy and targeted therapy to treat CRC patients, so as to explore the effectiveness of CIK treatment and the CRC subtypes more suitable for CIK treatment, thereby improving the survival rate and quality of life of CRC patients.
Detailed Description
Colorectal cancer (CRC) is a malignant tumor that seriously threatens human health, and according to the international agency for research on cancer (IARC) data, in 2018, the number of new cases of CRC totalled more than 1.8 million and the number of deaths totalled more than 88million, making it the third most common cancer worldwide [1]. In recent years, with the development of economic level in China, changes in lifestyle and dietary structure, the incidence and mortality of CRC have shown a continuous increasing trend, and it is ranked 5th in all malignant tumors. According to statistics, at present, our country has 376000 new CRC cases and 191000 deaths annually, and the whole face extremely serious challenges. Patients with advanced CRC have a more complicated disease, and the 5-year survival rate is even less than 5%. A single therapeutic means cannot achieve the desired therapeutic effect, and often multiple therapeutic modalities are used for intervention, including surgery, radiotherapy, chemotherapy, interventional minimally invasive treatment, immunotherapy and molecular targeting, etc. Because of the potential efficacy of CIK treatment in controlling tumor growth and prolonging patient survival, but there are still few clinical studies about CIK combined with other treatment modalities, this protocol is intended to use CIK combined with chemotherapy, immune and targeted therapy in CRC patients, in order to explore the effectiveness of CIK treatment and more suitable CRC subtypes for CIK treatment, and then improve the survival rate and quality of life of CRC patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Autologous cytokine induced killer cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CIK combined with chemotherapy group
Arm Type
Experimental
Arm Description
Combination of CIK cells and chemotherapy
Arm Title
CIK combined immunotherapy group
Arm Type
Experimental
Arm Description
Combination of CIK cells and immunotherapy
Arm Title
CIK combined targeted therapy group
Arm Type
Experimental
Arm Description
Combination of CIK cells and targeted therapy
Arm Title
CIK in combination with other therapies
Arm Type
Experimental
Arm Description
CIK in combination with any two or three of these (i.e., chemotherapy, immunotherapy, and targeted therapy) treatments
Intervention Type
Combination Product
Intervention Name(s)
CIK combined with chemotherapy group
Intervention Description
Combination of chemotherapy and autologous cytokine induced killer cells
Intervention Type
Combination Product
Intervention Name(s)
CIK combined immunotherapy group
Intervention Description
Combination of immunotherapy and autologous cytokine induced killer cells
Intervention Type
Combination Product
Intervention Name(s)
CIK combined targeted therapy group
Intervention Description
Combination of targeted therapy and autologous cytokine induced killer cells
Intervention Type
Combination Product
Intervention Name(s)
CIK in combination with other therapies
Intervention Description
CIK combined with any two or three of them (i.e. chemotherapy, immunotherapy and targeted therapy)
Primary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Disease control rate of colorectal cancer
Time Frame
up to 5 years
Title
objective response rate (ORR)
Description
objective response rate of colorectal cancer
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 18-70 years; Patients diagnosed with colorectal cancer, TNM stage III-IV; Had at least one extracranially measurable lesion by recist1.1 criteria; ④ Patients who had failed at least one or two prior lines of standard therapy or relapsed, or who were intolerant to or voluntarily abandoned one or two prior lines of standard therapy; ⑤ Expected survival ≥ 90 days; The major organs function normally; ⑦ The subject voluntarily joined this study, signed the informed consent, complied well and cooperated with the follow-up. Exclusion Criteria: Had participated in other clinical trialists of drugs within 4 weeks before the start of the study; Those who had hypertension that was inadequately controlled with a single antihypertensive agent (systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg, as judged by the investigator), had myocardial ischemia or myocardial infarction of grade I or higher, arrhythmia of grade I and higher (including QT interval ≥ 440 MS), or cardiac dysfunction; Those with a history of substance abuse who are unable to abstain or who have a history of mental disorders; Presence of fungal, bacterial, viral, or other infections that are not controllable or require antibiotic therapy; For subjects with prior chemotherapy use, ≥ grade 2 hematologic toxicity, or ≥ grade 3 nonhematologic toxicity according to nci-ctcae 5.0 criteria at enrollment; ⑥ Known presence of a history of HIV, or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) nucleic acid test positive; Presence of any indwelling catheter or drain (eg, biliary drain or pleural / peritoneal / pericardial catheter). Use of a dedicated central venous catheter was permitted (colostomy for patients with bowel cancer, percutaneous nephrostomy tube, indwelling Frey catheter, considered by the investigator for implications); ⑧ Presence of brain metastases, presence of a history or disease of the CNS such as seizure disorders, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
Facility Information:
Facility Name
Southwest Hospital, Army Medical University (Third Military Medical University)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shicang yu, M.D. and Ph.D.
Phone
023-68766452
Email
yushicang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27815354
Citation
Gammaitoni L, Giraudo L, Macagno M, Leuci V, Mesiano G, Rotolo R, Sassi F, Sanlorenzo M, Zaccagna A, Pisacane A, Senetta R, Cangemi M, Cattaneo G, Martin V, Coha V, Gallo S, Pignochino Y, Sapino A, Grignani G, Carnevale-Schianca F, Aglietta M, Sangiolo D. Cytokine-Induced Killer Cells Kill Chemo-surviving Melanoma Cancer Stem Cells. Clin Cancer Res. 2017 May 1;23(9):2277-2288. doi: 10.1158/1078-0432.CCR-16-1524. Epub 2016 Nov 4.
Results Reference
result
PubMed Identifier
31484350
Citation
Garofano F, Gonzalez-Carmona MA, Skowasch D, Schmidt-Wolf R, Abramian A, Hauser S, Strassburg CP, Schmidt-Wolf IGH. Clinical Trials with Combination of Cytokine-Induced Killer Cells and Dendritic Cells for Cancer Therapy. Int J Mol Sci. 2019 Sep 3;20(17):4307. doi: 10.3390/ijms20174307.
Results Reference
result
PubMed Identifier
28453697
Citation
Dienstmann R, Mason MJ, Sinicrope FA, Phipps AI, Tejpar S, Nesbakken A, Danielsen SA, Sveen A, Buchanan DD, Clendenning M, Rosty C, Bot B, Alberts SR, Milburn Jessup J, Lothe RA, Delorenzi M, Newcomb PA, Sargent D, Guinney J. Prediction of overall survival in stage II and III colon cancer beyond TNM system: a retrospective, pooled biomarker study. Ann Oncol. 2017 May 1;28(5):1023-1031. doi: 10.1093/annonc/mdx052.
Results Reference
result

Learn more about this trial

Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer

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