Actively Recruiting
CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-25
12
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This single-arm, open-label, dose-escalation trial aims to evaluate the safety and efficacy of CEA-targeted CAR-T cells and to obtain their pharmacokinetic profile in patients with advanced colorectal cancer and peritoneal metastases after cytoreductive surgery; the recommended dose will then be derived from these data.
CONDITIONS
Official Title
CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of informed consent.
- Pathologically confirmed colorectal cancer with peritoneal metastases.
- Patients who have failed standard treatments or have no effective options.
- Underwent cytoreductive surgery for peritoneal metastases with CC score of CC-0 to CC-2 and good postoperative recovery.
- No distant metastases outside the peritoneum on enhanced whole-abdominal CT scan.
- Tumor samples confirmed CEA-positive by immunohistochemistry (positive rate ≥10%).
- No metastatic sites outside the peritoneum and primary tumor resected.
- Expected survival time of at least 3 months.
- ECOG performance status of 0 or 1.
- Adequate organ function including hematology, cardiac, renal, liver function, and oxygen saturation >92%.
- Women of childbearing potential have negative pregnancy test and agree to use contraception.
- Male patients agree to use appropriate contraception.
- Ability to comply with study protocol and follow-up procedures.
You will not qualify if you...
- Unwilling to sign informed consent.
- Received or currently receiving anti-tumor therapy within 2 weeks prior to enrollment, except perioperative hyperthermic intraperitoneal chemotherapy.
- Active or uncontrolled bacterial, fungal, or viral infections.
- Other uncured malignant tumors except certain in situ carcinomas.
- History of severe asthma, active autoimmune disease, immunodeficiency, or requiring long-term immunosuppressive therapy (with some exceptions).
- History of mental illness.
- Uncontrolled comorbidities such as symptomatic heart failure, unstable angina, arrhythmia, severe coronary artery or cerebrovascular disease.
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral markers.
- Known hypersensitivity to study product components or immunotherapy.
- Pregnant or lactating women.
- Other serious diseases affecting follow-up or short-term survival.
- Other investigator-determined ineligibility.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310017
Actively Recruiting
Research Team
L
Lifeng Sun, MD
CONTACT
Y
Ying Yuan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here