Rectal cancer
Conditions
Interventions
Induction Therapy Group:Neoadjuvant therapy regimen combining sintilimab, CAPOX (capecitabine and oxaliplatin), and short-course radiotherapy (30 Gy), followed by radical surgery
Consolidation Therapy Group:Neoadjuvant therapy regimen combining sintilimab, CAPOX (capecitabine and oxaliplatin), and short-course radiotherapy (30 Gy), followed by radical surgery
Sponsors
The First Medical Center Of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ?(1) Pathologically confirmed rectal adenocarcinoma ?(2) Clinical stage: cT3-4N0 or cT1-4N+ (AJCC 8th edition) ?(3) Tumor located =18 years, no gender restrictions ?(7) Karnofsky Performance Status (KPS)>=70; ?Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (8) ?Fully informed and voluntarily sign informed consent, agreeing to: Use of blood, stool, and pathological specimens for research and compliance with study protocols (9) Willingness to adhere to the assigned treatment regimen (10) ?Baseline laboratory parameters (within 7 days prior to randomization) meeting the following criteria ?without transfusion/G-CSF/albumin/correctional drugs in the prior 14 days: 1)?Hematology: Neutrophils >=1.5×10^9/L Platelets >=75×10^9/L Hemoglobin >=90 g/L 2)Biochemistry: Serum creatinine 50 mL/min (Cockcroft-Gault formula) Total bilirubin =60 days after last dose ?Definition of childbearing potential, and there is no prior hysterectomy/bilateral oophorectomy; At least one menstrual period within 24 months post-natural menopause (cancer therapy-induced amenorrhea does not exclude fertility) ?*Male subjects with fertile female partners: Ensure partners comply with above contraception requirements.
Exclusion criteria
Exclusion criteria: (1) Pregnancy or lactation ?(2) History of other malignancies within 5 years prior to enrollment (except cured non-melanoma skin cancer, cervical carcinoma in situ, or other malignancies with sustained complete remission >=5 years) ?(3) Prior anticancer therapy, including but not limited to chemotherapy, radiotherapy, immune checkpoint inhibitors, T-cell therapy, or targeted therapy ?(4) Uncontrolled central nervous system disorders or psychiatric diseases (e.g., epilepsy, Alzheimer’s disease, schizophrenia) that, in the investigator’s judgment, may impair informed consent signing or treatment compliance (5) ?Severe comorbidities: Cardiac dysfunction (NYHA Class III-IV) or clinically significant arrhythmias; Moderate to severe hepatic or renal insufficiency (Child-Pugh Class B/C or eGFR 10 mg/day prednisone equivalent) for immunosuppression within 4 weeks before treatment initiation (9) ?Active infections: HIV-1/2 antibody positivity, HBV (HBsAg+ or HBV DNA >=500 IU/mL), HCV (anti-HCV+ with detectable HCV RNA), Syphilis (TPPA+ with RPR titer >=1:8) Active tuberculosis (positive T-SPOT.TB or sputum culture) ?(10) Hypersensitivity to any component of the investigational drugs (e.g., sintilimab, capecitabine, oxaliplatin) ?(11) Other exclusionary factors per investigator assessment: Alcohol/drug abuse Major surgery within 4 weeks before treatment Gastrointestinal disorders impairing capecitabine absorption (e.g., Crohn’s disease, ileostomy) Life expectancy <5 years due to comorbidities Clinically significant laboratory abnormalities (e.g., uncorrectable hypokalemia) Social/familial factors compromising protocol adherence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response;3 years/ 5 years disease-free survival rate;3 years/ 5 years overall survival rate;incidence rate of Grade 3-4 acute adverse reactions;surgical complication;quality of life; | — |
Countries
China
Contacts
Public ContactZhang Chaojun
The First Medical Center Of Chinese PLA General Hospital
Outcome results
None listed