Actively Recruiting
Safety and Efficacy of CEA-Directed CAR-T Cell Immunotherapy in Advanced Colorectal Cancer with Peritoneal Metastases After Cytoreductive Surgery
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-25
12
Participants Needed
1
Research Sites
21 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
Researchers are evaluating the safety, preliminary effectiveness, and behavior of CEA-targeted CAR-T cells given to patients with advanced colorectal cancer and peritoneal metastases after cytoreductive surgery. This phase 1, single-arm, open-label dose-escalation study aims to identify the recommended dose by testing three dose levels. The study focuses on patients who have undergone surgery and have limited cancer spread confined to the peritoneum. Participants will receive an intraperitoneal infusion of autologous CAR-T cells targeting CEA after preparing with conditioning therapy using Fludarabine and Cyclophosphamide. Doses of 1 x 10^5, 3 x 10^5, and 5 x 10^5 CAR-T cells per kg will be tested to assess safety and dosing. The trial monitors patients starting from infusion through 3 months, with extended follow-up up to 2 years for long-term safety and effectiveness. Throughout the study, participants will be closely monitored for safety, including side effects and toxicity, from infusion through the first 3 months, and their cancer progression will be tracked up to 2 years. Researchers will use imaging scans, laboratory tests, and clinical assessments to evaluate progression-free survival, overall survival, and disease recurrence. Follow-up visits and tests will ensure careful observation of the CAR-T therapy's impact over time.
CONDITIONS
Brief 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 consent
- Pathologically confirmed colorectal cancer with peritoneal metastases
- Failed standard treatments or have no effective treatment options
- Underwent cytoreductive surgery with CC score CC-0 to CC-2 and good postoperative recovery
- No distant metastases outside the peritoneum on recent CT scan
- Tumor samples confirmed CEA-positive by immunohistochemistry (≥10% positive rate)
- Primary tumor resected, no metastases outside peritoneum
- Expected survival of at least 3 months
- ECOG performance status 0 or 1
- Adequate organ function including blood counts, heart, kidney, liver, and oxygen saturation
- Women of childbearing potential with negative pregnancy test and using contraception
- Male patients agree to use contraception
- Able to comply with study protocol and follow-up
You will not qualify if you...
- Unwilling to sign informed consent
- Received anti-tumor drug therapy within 2 weeks prior to enrollment (except perioperative chemotherapy)
- Active or uncontrolled infections
- Other untreated malignant tumors except certain carcinoma in situ
- History of severe asthma, active autoimmune disease, immunodeficiency, or long-term immunosuppressive therapy (except certain exceptions)
- History of mental illness
- Uncontrolled comorbidities such as heart failure, unstable angina, severe coronary or cerebrovascular disease
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral levels
- Known hypersensitivity to study product components or immunotherapy
- Pregnant or breastfeeding women
- Other serious diseases affecting follow-up or survival
- Other investigator-determined ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From infusion through Month 3
Participants receive conditioning therapy followed by an intraperitoneal infusion of CEA-targeted CAR-T cells to treat advanced colorectal cancer with peritoneal metastases after cytoreductive surgery.
Multiple visits during the 3-month treatment period
Duration - Up to 2 years
Participants are monitored for long-term safety, effectiveness, and survival outcomes after treatment.
Periodic visits during the 2-year follow-up
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
Y
Ying Yuan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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