MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis
Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · May 29, 2024
Trial Information
Current as of February 18, 2025
Not yet recruiting
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
- • 2. Age 18-80.
- • 3. Pathological examination confirmed colorectal adenocarcinoma.
- 4. For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):
- • a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check \< 12 nodes
- • 5. Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
- • 6. There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
- • 7. Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
- • 8. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.
- • 9. Expected survival ≥ 3 months.
- • 10. Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative.
- Exclusion Criteria:
- • 1. Stage I patients and stage II patients without risk factors or MSI-H.
- • 2. Stage IV patients who cannot be surgically resected.
- • 3. Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy.
- • 4. Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance.
- • 5. Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy)
- 6. Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:
- • 1. Stage 1B or below cervical cancer.
- • 2. Non-invasive basal cell or squamous cell skin cancer.
- • 3. Non-invasive superficial bladder cancer.
- • 4. Prostate cancer with a current PSA level \< 0.1 ng/mL.
- • 5. Any curable cancer with a complete response (CR) duration of \> 2 years.
- • 7. Patients with hematological and autoimmune diseases.
- • 8. Patients with active hepatitis B or C.
- • 9. Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research.
- • 10. Pregnant and lactating women.
- • 11. Patients with mental illness, senile dementia, etc.
About Second Affiliated Hospital Of Wenzhou Medical University
The Second Affiliated Hospital of Wenzhou Medical University is a leading clinical research institution in China, renowned for its commitment to advancing medical knowledge and improving patient care. As a prominent teaching hospital, it integrates clinical practice with innovative research and education, fostering a collaborative environment for healthcare professionals. The hospital is equipped with state-of-the-art facilities and a diverse range of specialized departments, enabling it to conduct comprehensive clinical trials across various medical fields. Its mission is to enhance healthcare outcomes through rigorous scientific inquiry and to contribute to the global body of medical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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