Status:
NOT_YET_RECRUITING
Node-Sparing Short-Course Radiation with CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: a Randomized, Prospective, Multicenter Study
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Microsatellite Stable (MSS) Colon Cancer
Locally Advanced Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the use of node-sparing short-course radiotherapy combined with chemotherapy and Sintilimab, or chemotherapy alone, as neoadjuvant therapy for MSS-type locally advanced col...
Detailed Description
Colorectal cancer is currently one of the most common malignant tumors in China. According to the latest data released by the National Cancer Center, it ranks second in incidence and fourth in mortali...
Eligibility Criteria
Inclusion
- 1\. Patients willing to undergo neoadjuvant treatment. 2. Age ≥ 18 years. 3. Tumor confirmed by colonoscopy and enhanced abdominal CT to be ≥ 12 cm from the anal verge.
- 4\. Histologically diagnosed adenocarcinoma; genetic testing indicates MSI-L or MSS, or immunohistochemistry from tumor biopsy shows pMMR (all four proteins-MSH1, MSH2, MSH6, and PMS2-are positive).
- 5\. Clinical staging by enhanced abdominal CT evaluates as cT3-4N0-2M0. 6. ECOG performance status score of 0-1. 7. No prior treatment with anti-tumor, immunotherapy, or abdominal radiation therapy before enrollment.
- 8\. Blood test results (without transfusion within 14 days and no use of granulocyte colony-stimulating factor or other hematopoietic stimulators within 7 days before the lab test):
- White blood cell count ≥ 3.5 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin concentration ≥ 9 g/dL;
- Liver function tests (bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 5 × ULN);
- Renal function (serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min);
- Coagulation (INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN);
- Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, FT3 and FT4 levels must be evaluated, and if FT3 and FT4 are normal, the patient is eligible.
- 9\. Voluntary participation with a signed informed consent form.
Exclusion
- 1\. History of other malignancies within the past 5 years. 2. Patients with metastases in other locations (stage IV). 3. Patients with MSI-H or dMMR. 4. Patients with conditions such as bowel obstruction, perforation, or bleeding requiring emergency surgery.
- 5\. Known allergy to the study drug or any of its excipients. 6. Patients with any unstable systemic diseases, including but not limited to severe infections, uncontrolled diabetes, uncontrolled hypertension, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction, congestive heart failure, or severe illnesses requiring medication (such as arrhythmias, liver, kidney, or metabolic diseases) that are life-threatening.
- 7\. History of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the last 2 years. Replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments.
- 8\. Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). 9. Receipt of any investigational drug (including immunotherapy) or participation in another interventional clinical study within 30 days before screening.
- 10\. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; men or women unwilling to use effective contraception during the study.
- 11\. Vulnerable populations, including those with mental illness, cognitive impairment, or critically ill patients.
- 12\. Any other conditions deemed inappropriate for participation by the investigator.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06594692
Start Date
October 1 2024
End Date
September 30 2026
Last Update
September 19 2024
Active Locations (2)
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1
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, China, 310016
2
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310016