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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07394192
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years old, regardless of sex.
* Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge.
* Pathologically confirmed rectal adenocarcinoma.
* Imaging examinations (including pelvic MRI and chest-abdominal CT) confirm a clinical stage of II/III (cT3-T4aN0 or cT2-4aN+, MRF (-), with no distant metastasis) according to the AJCC Cancer Staging Manual, 8th Edition (2018) (for detailed TNM staging of rectal cancer).
* If N+, metastatic lymph nodes are confined to the mesorectal and superior rectal artery drainage regions, with no lateral pelvic lymph node metastasis.
⑥ Confirmed by immunohistochemistry or molecular testing to be mismatch repair proficient (pMMR) or microsatellite stable (MSS).
⑦ Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1 (see Appendix 2 for details).
⑧ Meeting the following laboratory criteria: Hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L; Creatinine ≤ 1.0 × upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 1.0 × ULN; Alanine aminotransferase (ALT) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase (ALP) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Urine protein negative; normal coagulation time; normal thyroid function.
⑨ Patients with primary rectal cancer must have undergone no surgical interventions (excluding palliative stoma formation), chemotherapy, or other antitumor treatments from the time of diagnosis to enrollment.
⑩ The planned radiation field must have no history of prior radiotherapy.
* The patient voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up visits and data provision.
Exclusion Criteria:
* Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.
* Patients with severe autoimmune diseases are excluded, including active inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.
* Patients with symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis are excluded.
* Patients with clinical or imaging evidence of intestinal obstruction or perforation, or those deemed by the investigator to be at high risk of perforation or hemorrhage, are excluded.
* History of other malignancies, excluding curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix, are excluded.
* Patients with severe cardiovascular or cerebrovascular diseases are excluded, including cerebrovascular accidents, transient ischemic attacks, myocardial infarction within 6 months prior to enrollment, or significant vascular diseases (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis). Also excluded are those with poorly controlled cardiac symptoms or conditions, such as unstable angina, heart failure of New York Heart Association (NYHA) Class II or higher, left ventricular ejection fraction (LVEF) \< 50% on echocardiography, or severe arrhythmias uncontrolled by medication.
* Physical examination findings, clinical laboratory abnormalities, or other uncontrolled conditions that, in the investigator's judgment, may interfere with the study results or increase the patient's risk of treatment complications are excluded.
* Lactating or pregnant women are excluded. ⑨ Patients with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV) infection, or a history of organ transplantation or allogeneic stem cell transplantation, are excluded.
⑩ Known active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis are excluded.
⑪ Patients with concurrent use of other immunomodulators, chemotherapeutic agents, other investigational drugs, or requiring long-term corticosteroid therapy are excluded.
⑫ Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance, as determined upon physician review, are excluded.
⑬ Patients with allergies or contraindications to the investigational drug(s) are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07394192
Study Brief:
Protocol Section:
NCT07394192