Using autologous cell factor induced killer cells to treat colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Southwest Hospital, Army Medical University (Third Military Medical University)
  Chongqing, Chongqing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.