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New treatment option for Colorectal Cancer
Official title Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases
ClinicalTrials.gov ID: NCT05240950
What this study is testing
What is Anti-CEA CAR-T Cells?
Anti-CEA CAR-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Recurrence of liver metastasis in colorectal cancer after R0 resection is mainly due to the invisible minimal residual disease, which are the main factors leading to metastasis and recurrence. Positive circulating tumor DNA (ctDNA) is the direct evidence of the minimal residual disease (MRD).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- ≥18 years old, ≤75 years old, male or female;
- Patients diagnosed with liver metastasis of colorectal cancer underwent radical surgery for the primary lesion of colorectal cancer, and R0 resection...
- Patients with CEA expression detected by immunohistochemistry in primary tumor and liver metastasis tumor tissues (CEA expression detected by...
- Life expectancy ≥6 months;
- Performance status (PS) score 0-2, Karnofsky performance status (KPS) score above 60;
You likely can't join if
- Have a history of severe central nervous system diseases;
- Residual disease or tumor remnants can be seen in imaging, or tumor lesions cannot be resected in other tissues or organs;
- The presence of serious non-malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive...
- Prior treatment with CAR-T or other gene-modified T cells;
- Participated in other clinical studies within 30 days prior to screening or plan to participate in other clinical studies during the study period;
- Patients with active Hepatitis B (HBV-DNA copy number \>105copies/ml), active Hepatitis C (HCV-RNA copy number \>ULN), HIV infection, treponema...
See the full eligibility criteria
- ≥18 years old, ≤75 years old, male or female;
- Patients diagnosed with liver metastasis of colorectal cancer underwent radical surgery for the primary lesion of colorectal cancer, and R0 resection was performed for the liver metastasis (R0 resection was required for...
- Patients with CEA expression detected by immunohistochemistry in primary tumor and liver metastasis tumor tissues (CEA expression detected by pathology was more than 50%);
- Life expectancy ≥6 months;
- Performance status (PS) score 0-2, Karnofsky performance status (KPS) score above 60;
- Patients with ctDNA MRD still positive or positive again after adjuvant chemotherapy (including preoperative neoadjuvant chemotherapy);
- Important organ functions are sufficient, such as New York Heart Association (NYHA) heart function grade III or above, hemoglobin ≥90g/L, hypoxia; Liver function: total bilirubin ≤1.5×ULN (total bilirubin ≤3×ULN in...
- Sufficient mononuclear cells (PBMC) can be obtained from peripheral veins without contraindications;
- Patients of childbearing age had no birth plan within 1 year after cell infusion and took effective contraceptive measures.
- Have a history of severe central nervous system diseases;
- Residual disease or tumor remnants can be seen in imaging, or tumor lesions cannot be resected in other tissues or organs;
- The presence of serious non-malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
- Prior treatment with CAR-T or other gene-modified T cells;
- Participated in other clinical studies within 30 days prior to screening or plan to participate in other clinical studies during the study period;
- Patients with active Hepatitis B (HBV-DNA copy number \>105copies/ml), active Hepatitis C (HCV-RNA copy number \>ULN), HIV infection, treponema pallidum infection at screening time;
- The existence of uncontrollable systemic infectious diseases;
- Other multiple malignant tumors in addition to colorectal cancer and its metastasis;
- Chinese herbal medicine, systemic glucocorticoids or other immunosuppressants may be required within 2 weeks prior to enrollment or during the trial period, which may negatively affect lymphocyte activity or number;
- Pregnancy and lactation;
- The existence of severe gastroduodenal ulcer, severe ulcerative colitis and other serious intestinal inflammation;
- The existence of serious respiratory diseases;
- Those who cannot provide enough white tablets for tumor pathology for next-generation sequencing (NGS) detection (at least 3 white tablets are expected);
- The investigator judged that there were other conditions that were not suitable for the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.