Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT05338866
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed as rectal adenocarcinoma.
2. MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
3. The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
4. MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
5. No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
6. Age: 18 \~ 80 years old.
7. ECOG score: 0-1.
8. Expected life: more than 3 years.
9. Hematology: WBC \> 3 × 109/L; PLT\>80 × 109/L; Hb\>90g/L.
10. Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
11. Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
12. Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.
Exclusion Criteria:
1. There are any conditions that make MRI impossible.
2. There are serious medical complications.
3. Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
4. Any unstable condition or situation that may endanger patient safety and compliance.
5. Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
6. Refuse to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05338866
Study Brief:
Protocol Section:
NCT05338866