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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06577194
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged between 18 and 70 years;
* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
* Tumor tissue samples obtained and histologically confirmed as rectal adenocarcinoma;
* Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10\^9/L; platelet count ≥ 75×10\^9/L; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.
Exclusion Criteria:
* Metastatic disease (Stage IV);
* Recurrent rectal cancer;
* Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone;
* Previous systemic anti-cancer treatment for colorectal cancer;
* Coexistence of other non-colorectal cancer malignancies;
* Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs;
* Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);
* Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation);
* Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;
* Pregnant or breastfeeding women;
* Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
* Known or suspected allergy history to any drugs used in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06577194
Study Brief:
Protocol Section:
NCT06577194