NCT05676190Recruiting
Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer
Treatment of Colorectal Cancer With Autologous Cytokine Induced Killer Cells (CIK)
Source: ClinicalTrials.gov · Last updated 9 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 9 Jan 2023
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- ShiCang Yu
- Diseases
- Colorectal cancer
- NCT number
- NCT05676190
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 9 Jan 2023 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southwest Hospital, Army Medical University (Third Military Medical University) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.