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

Colorectal Cancer Clinical Trial

Official title:

Treatment of Colorectal Cancer With Autologous Cytokine Induced Killer Cells (CIK)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676190
• Other study ID #: zsyx2
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: December 2022
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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; ? 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; ? Expected survival = 90 days;

• The major organs function normally; ? 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; ? 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); ? 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;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Combination Product:
• CIK combined with chemotherapy group
Combination of chemotherapy and autologous cytokine induced killer cells
• CIK combined immunotherapy group
Combination of immunotherapy and autologous cytokine induced killer cells
• CIK combined targeted therapy group
Combination of targeted therapy and autologous cytokine induced killer cells
• CIK in combination with other therapies
CIK combined with any two or three of them (i.e. chemotherapy, immunotherapy and targeted therapy)

Locations

Country	Name	City	State
China	Southwest Hospital, Army Medical University (Third Military Medical University)	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
ShiCang Yu

Country where clinical trial is conducted

China, 

References & Publications (3)

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 surviva — View 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. — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (DCR)	Disease control rate of colorectal cancer	up to 5 years
Primary	objective response rate (ORR)	objective response rate of colorectal cancer	up to 5 years