Using autologous cell factor induced killer cells to treat colorectal cancer
Treatment of Colorectal Cancer With Autologous Cytokine Induced Killer Cells (CIK)
This study is testing whether a new treatment using special immune cells can help advanced colorectal cancer patients who haven't had success with standard therapies feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Southwest Hospital, China Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05676190 on ClinicalTrials.gov |
What this trial studies
This clinical project aims to evaluate the efficacy of autologous cytokine-induced killer (CIK) cells in combination with chemotherapy, immunotherapy, and targeted therapy for patients with colorectal cancer (CRC). The study will focus on advanced CRC patients, specifically those with TNM stage III-IV, who have previously failed standard therapies. By exploring the effectiveness of CIK treatment and identifying CRC subtypes that respond best to this approach, the study seeks to improve patient survival rates and quality of life. The trial will involve multiple treatment groups to assess the combined effects of CIK cells with various therapeutic modalities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with advanced colorectal cancer (TNM stage III-IV) who have failed prior standard therapies.
Not a fit: Patients with well-controlled hypertension or those who have participated in other clinical trials within the last four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced colorectal cancer.
How similar studies have performed: While there is limited research on CIK combined with other therapies, the potential efficacy of CIK treatment in cancer control suggests that this approach may yield promising results.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Chongqing, Chongqing Municipality
- Southwest Hospital, Army Medical University (Third Military Medical University) — Chongqing, Chongqing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.