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Colorectal CancerNCT05676190

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

A study testing CIK combined with chemotherapy group, CIK combined immunotherapy group and CIK combined targeted therapy group in people with Colorectal Cancer, run by ShiCang Yu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colorectal Cancer
What is being tested?
CIK combined with chemotherapy group, CIK combined immunotherapy group and CIK combined targeted therapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
9 Jan 2023to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

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

    Chongqing, Chongqing Municipality, 400038

    shicang yu, M.D. and Ph.D., 023-68766452, yushicang@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
CIK combined with chemotherapy group, CIK combined immunotherapy group, CIK combined targeted therapy group, CIK in combination with other therapies
Keywords
Autologous cytokine induced killer cells
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIK combined with chemotherapy groupCombination product

    Combination of chemotherapy and autologous cytokine induced killer cells

  • CIK combined immunotherapy groupCombination product

    Combination of immunotherapy and autologous cytokine induced killer cells

  • CIK combined targeted therapy groupCombination product

    Combination of targeted therapy and autologous cytokine induced killer cells

  • CIK in combination with other therapiesCombination product

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

Study groups in NCT05676190
Study groupRoleWhat they receive
CIK combined with chemotherapy groupExperimentalCombination of CIK cells and chemotherapy
Receives: Combination Product: CIK combined with chemotherapy group
CIK combined immunotherapy groupExperimentalCombination of CIK cells and immunotherapy
Receives: Combination Product: CIK combined immunotherapy group
CIK combined targeted therapy groupExperimentalCombination of CIK cells and targeted therapy
Receives: Combination Product: CIK combined targeted therapy group
CIK in combination with other therapiesExperimentalCIK in combination with any two or three of these (i.e., chemotherapy, immunotherapy, and targeted therapy) treatments
Receives: Combination Product: CIK in combination with other therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR)

    Disease control rate of colorectal cancer

    Measured: up to 5 years

  2. objective response rate (ORR)

    objective response rate of colorectal cancer

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start9 Jan 2023 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676190
Sponsor's protocol ID
zsyx2
Status last verified
Dec 2022
First submitted
8 Dec 2022
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27815354

  • 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.

    PubMed 31484350

  • 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.

    PubMed 28453697

Questions about this trial

What is this clinical trial studying?

A study testing CIK combined with chemotherapy group, CIK combined immunotherapy group and CIK combined targeted therapy group in people with Colorectal Cancer, run by ShiCang Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05676190, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.

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