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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06333769
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years, any gender.
* Pathologically confirmed rectal adenocarcinoma.
* Baseline MR stage T3-4/N+.
* Distance from anal verge ≤12cm.
* No distant metastasis.
* Karnofsky Performance Status ≥70.
* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
* Microsatellite/mismatch repair status MSS/pMMR.
* No prior chemotherapy or any other anti-tumor treatment before inclusion.
* No prior immunotherapy.
* Ability to comply with the study protocol during the study period.
* Signed written informed consent.
Exclusion Criteria:
* Pregnant or lactating women.
* Pathological diagnosis of signet ring cell carcinoma.
* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
* Patients with autoimmune diseases.
* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
* Known deficiency of dihydropyrimidine dehydrogenase (DPD).
* Allergy to any investigational drug components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06333769
Study Brief:
Protocol Section:
NCT06333769