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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT03443661
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed locally advanced rectal cancer;
2. 18-70 years ；
3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
4. Tumor from anus \>5cm and ≤15cm;
5. ECOG=0-1;
6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
7. Informed consent;
8. UGT1A1:UGT1A1\*1/UGT1A1\*1,UGT1A1\*1/UGT1A1\*28,UGT1A1\*1/UGT1A1\*6;
Exclusion Criteria:
1. Clinical stage T4b or unresectable disease;
2. History of pelvic radiotherapy;
3. History of chemotherapy within 5 years;
4. History of chronic diarrhea;
5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
7. UGT1A1:UGT1A1\*28/UGT1A1\*28,UGT1A1\*6/UGT1A1\*6;
8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
10. Mental illness;Pregnant or lactating women;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03443661
Study Brief:
Protocol Section:
NCT03443661