rectal cancer
Conditions
Interventions
Intervention group:Sequential radiotherapy and chemotherapy followed by Cadonilimab
Sponsors
HEBEI GENERAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria (Potential subjects must meet all of the following criteria to be included in this study): (1) Voluntarily signed written informed consent before screening; (2) Age =18 years old at the time of signing informed consent, regardless of gender; (3) ECOG performance status score of 0-2; (4) T3-T4/N+ rectal cancer patients: Pathologically/cytopathologically confirmed rectal adenocarcinoma without distant metastasis; tumor located within 10cm of the anal verge; (5) Agree to undergo radical surgical treatment and judged by a surgeon as having no surgical contraindications; (6) According to RECIST 1.1 criteria, patients must have measurable target lesions, and tumor imaging evaluation should be performed within 28 days before the first administration; (7) Have not received previous systemic treatment for the current disease, including surgical treatment, anti-tumor radiotherapy/chemotherapy/immunotherapy, etc.; (8) Expected survival time >6 months; (9) Able to take oral medication; (10) Have adequate bone marrow and organ function: ? Routine blood test: a. neutrophil absolute value =1.5109/L; b. platelet count =100109/L; c. hemoglobin =90g/L; ? Liver function: a. serum total bilirubin =1.5ULN; b. AST and ALT =2.5ULN; ? Renal function: a. serum creatinine =1.5ULN; b. creatinine clearance rate (CrCL) =60ml/minn (Cockcroft-Gault formula); c. serum albumin =30g/L ? Cardiac function: a. left ventricular ejection fraction (LVEF) =50%; b. QTcF=480msec; c. troponin (cTnI) =1ULN; d. creatine kinase (CK) =1ULN; e. creatine kinase isoenzyme (CK-MB) =1ULN; ? Coagulation function: a. international normalized ratio (INR) or prothrombin time (PT) =1.5ULN; b. activated partial thromboplastin time (APTT) =1.5ULN; (11) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) levels within the normal range, but allowing a slight increase in baseline TSH as long as total T3 (or FT3) and FT4 levels are also within the normal range; (12) Fertile female subjects must have a negative pregnancy test and be willing to use effective and reliable contraception measures during the clinical trial period; (13) If a non-sterile male subject has sexual relations with a fertile female partner, the subject must use effective contraception from the start of screening until 120 days after the last dose of study treatment; regarding whether to discontinue contraception after this point, the investigator should be consulted; (14) Subjects are willing and able to adhere to the scheduled visits, treatment protocol, laboratory tests, and comply with the study's procedures.
Exclusion criteria
Exclusion criteria: Exclusion criteria (Potential subjects meeting any of the following criteria must be excluded from the study): (1) Subjects with other malignancies; (2) Subjects with recurrent rectal cancer or a history of pelvic radiotherapy; (3) Subjects with active or prior history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); (4) Subjects with a history of interstitial lung disease or non-infectious pneumonia requiring systemic glucocorticoid treatment; (5) Subjects who have received prior immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRPa antibodies, anti-LAG-3 antibodies), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies), and immune cell therapies; (6) Severe infections within 4 weeks prior to the first dose of study treatment, including but not limited to infections requiring hospitalization, sepsis, or severe pneumonia; systemic anti-infective therapy for active infections within 2 weeks prior to the first dose of study treatment (excluding anti-viral therapy for hepatitis B or C); (7) Systemic treatment with traditional Chinese medicine or immunomodulatory agents (including thymosin, interferon, interleukin) for tumors within 2 weeks prior to the first dose of study treatment; (8) Subjects with active, known, or suspected autoimmune diseases; HIV antibody positive subjects; long-term use of systemic corticosteroids or other immunosuppressive agents; I type diabetes mellitus receiving stable-dose insulin treatment and patients with skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and have not had acute exacerbation within 2 years before screening; (9) Subjects with known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; (10) Major surgery within the past 6 months (determined by the investigator); (11) Prior history of myocarditis, cardiomyopathy, or malignant arrhythmias; unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association functional class 2 or higher), or vascular diseases (such as aortic aneurysms at risk of rupture) requiring hospitalization for unstable angina pectoris, myocardial infarction, or congestive heart failure within the past 12 months before the first dose of study treatment; any arterial thrombotic events within the past 6 months before the first dose of study treatment, venous thromboembolic events of NCI CTCAE grade 3 or higher within the past 5.0 months before the first dose of study treatment, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within the past 1 month before the first dose of study treatment; chronic obstructive pulmonary disease exacerbation within 1 month before the first dose of study treatment; current hypertension with systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg despite oral antihypertensive treatment. (12) Active hepatitis B (HBsAg positive with HBV-DNA > 1000 copies/ml (200 IU/ml) or above the detection limit), subjects with hepatitis B require anti-hepatitis B virus treatment during the study; active hepatitis C (HCV antibody positive with HCV-RNA levels above the detection limit). (13) Known active tuberculosis (TB), subjects suspected of having active TB require clinical exclusion; kn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Quality of life assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Clinical downstaging rate;Pathological response rate (MPR);Disease-free survival (DFS);Overall survival (OS);Objective response rate (ORR);Disease control rate (DCR);Safety; | — |
Countries
CHINA
Contacts
Public ContactJiaYiTao
HEBEI GENERAL HOSPITAL
Outcome results
None listed