CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases

Inclusion Criteria

• •1. Aged ≥18 years and ≤75 years at the time of informed consent signing.
• •2. Pathologically confirmed colorectal cancer with peritoneal metastases.
• •3. Patients who have failed standard treatments (disease progression or intolerance, e.g., failure of oxaliplatin, irinotecan, fluorouracil, etc.) or have no effective treatment options.
• •4. Underwent cytoreductive surgery for peritoneal metastases from colorectal cancer, with cytoreduction completeness (CC) score of CC-0 to CC-2. Postoperative recovery is good, without severe postoperative complications. A baseline enhanced whole-abdominal CT scan (within 1 week before or after 1 month post-surgery) shows no distant metastases outside the peritoneum (e.g., liver, lung, bone, brain).
• •5. Tumor samples resected during cytoreductive surgery are confirmed CEA-positive by immunohistochemistry (distinct membranous staining, positive rate ≥10%).
• •6. Regardless of synchronous or metachronous peritoneal metastases, there are no metastatic sites outside the peritoneum, and the primary tumor has been resected.
• •7. Expected survival time of at least 3 months.
• •8. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
• •9. Unless otherwise specified, subjects must have adequate organ function as follows:
• •1. Hematology: White blood cell (WBC) count ≥3.5×10⁹/L, neutrophil count ≥1.8×10⁹/L, lymphocyte count \>0.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥90g/L.
• •2. Cardiac function: Echocardiography shows left ventricular ejection fraction (LVEF) \>50%, and electrocardiogram (ECG) shows no significant abnormalities.
• •3. Renal function: Serum creatinine ≤2.0×ULN, blood urea nitrogen (BUN) ≤1.5×ULN.
• •4. Liver function: ALT and AST ≤3.0×ULN; total bilirubin ≤2.0×ULN (≤3.0×ULN for Gilbert's syndrome).
• •5. Oxygen saturation \>92% without oxygen supplementation.
• •10. Women of childbearing potential have a negative pregnancy test within 7 days prior to enrollment, have no immediate plans for pregnancy, and agree to use contraceptive measures (or other fertility control methods) before and during the trial.
• •11. Male patients agree to use appropriate contraceptive methods.
• •12. Able to comply with the study protocol and follow-up procedures.