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

NCT05676190 | Recruiting DMC

• 1 other identifier: zsyx2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Autologous cytokine induced killer cells

Outcome Measures

Primary Outcomes (2)

• Disease control rate (DCR)

  Disease control rate of colorectal cancer

  up to 5 years

• objective response rate (ORR)

  objective response rate of colorectal cancer

  up to 5 years

Study Arms (4)

CIK combined with chemotherapy group

EXPERIMENTAL

Combination of CIK cells and chemotherapy

Combination Product: CIK combined with chemotherapy group

CIK combined immunotherapy group

EXPERIMENTAL

Combination of CIK cells and immunotherapy

Combination Product: CIK combined immunotherapy group

CIK combined targeted therapy group

EXPERIMENTAL

Combination of CIK cells and targeted therapy

Combination Product: CIK combined targeted therapy group

CIK in combination with other therapies

EXPERIMENTAL

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

Combination Product: CIK in combination with other therapies

Interventions

CIK in combination with other therapies COMBINATION_PRODUCT

CIK combined with any two or three of them (i.e. chemotherapy, immunotherapy and targeted therapy)

CIK in combination with other therapies

CIK combined with chemotherapy group COMBINATION_PRODUCT

Combination of chemotherapy and autologous cytokine induced killer cells

CIK combined with chemotherapy group

CIK combined immunotherapy group COMBINATION_PRODUCT

Combination of immunotherapy and autologous cytokine induced killer cells

CIK combined immunotherapy group

CIK combined targeted therapy group COMBINATION_PRODUCT

Combination of targeted therapy and autologous cytokine induced killer cells

CIK combined targeted therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ShiCang Yu: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 27815354 RESULT

• 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.

  PMID: 31484350 RESULT

• 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.

  PMID: 28453697 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 9, 2023
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)