Rectal cancer
Conditions
Interventions
Short-course Radiation Therapy Cohort:Atezolizumab combined with short-course radiation therapy (5×5Gy) and CAPOX chemotherapy regimen
Long-course Radiation Therapy Cohort:Atezolizumab combined with long-course radiation therapy (1.8Gy × 25-28 fractions) and CAPOX chemotherapy regimen
Sponsors
Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures 2. Male or female, aged 18 years or older, up to 85 years old 3. Patients diagnosed with rectal adenocarcinoma via histological examination of biopsy tissue from the primary tumor site 4. Patients judged by imaging and colonoscopy as resectable and requiring neoadjuvant therapy, with cT stage >= T3 or cN stage N1+, M0, or EMVI (+), or MRF (+), or suspicious lateral lymph node metastasis (>5mm) 5. Patients judged by imaging and colonoscopy to have the main body of the tumor located =1.5x10^9/L without granulocyte colony-stimulating factor use within the past 14 days. (2) Platelet count >=100x10^9/L without transfusion within the past 14 days. (3) Hemoglobin >9g/dL without transfusion or erythropoietin use within the past 14 days. (4) Total bilirubin =60 ml/min. (7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 times ULN. (8) Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within normal ranges may also be enrolled. (9) Normal cardiac enzyme profile (subjects with purely laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled) 11. For women of childbearing potential, a urine or serum pregnancy test performed within 3 days prior to the first administration of the investigational drug (Day 1, Cycle 1) must yield a negative result. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential females are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. If there is a risk of conception, all subjects (regardless of gender) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the investigational drug (or 180 days after the last dose of chemotherapy drugs)
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignancies within 5 years prior to the first dose that are not cured (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ treated with radical resection); 2. Patients with advanced rectal cancer with distant metastasis; 3. Currently participating in interventional clinical study treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 4. Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137); 5. Receipt of systemic traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, excluding local use for controlling pleural effusion) within 2 weeks prior to the first dose; 6. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 7. Receiving systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug; Note: Use of physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) is permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known allergy to the active ingredient or excipients of the study drug adebrelimab; 10. Presence of multiple factors affecting oral medication (e.g., inability to swallow, post-gastrectomy, chronic diarrhea, and intestinal obstruction); 11. Failure to adequately recover from toxicity and/or complications caused by any intervention prior to starting treatment (i.e., <=Grade 1 or returned to baseline, excluding fatigue or alopecia); 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal of the research center's laboratory); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: (1) HBV viral load <1000 copies/ml (200 IU/ml) prior to the first dose; subjects should receive anti-HBV treatment throughout the study chemotherapy period to avoid viral reactivation. (2) For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary. 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 15. Receipt of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Receipt of injectable inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose is permitted; however, receipt of live attenuated influenza vaccine via intranasal administration is not permitted. 16. Pregnant or breastfeeding women; 17. Presence of any severe or uncontrolled systemic disease, such as: (1) Significant and symptomatic abnormaliti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (Pathological Complete Response rate [pCR] and Clinical Complete Response rate [cCR]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Response Rate (PR);Objective Response Rate (ORR);2-Year Disease-Free Survival Rate;3-Year Overall Survival Rate;R0 Resection Rate; | — |
Countries
China
Contacts
Public ContactJing Changqing
Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed