Locally advanced rectal cancer
Conditions
Interventions
Group D:LCRT?6cycles*(CAPOX+PD-1 antibody)?Surgery/NOM
Group C:LCRT?4 cycles*(CAPOX+PD-1 antibody)?Surgery/NOM
Group B:SCRT?6 cycles*(CAPOX+PD-1 antibody)?Surgery/NOM
Group A:SCRT?4 cycles*(CAPOX+PD-1 antibody)?Surgery/NOM
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, regardless of gender. 2. Pathological immunohistochemistry showing pMMR or genetic testing confirming MSS status. 3. MRI or endoscopic ultrasound staging as II/III (cT3-T4N0 or cT2-4N+, without distant metastasis, per AJCC Cancer Staging Manual 8th Edition 2018) and meeting any of the following: (1) cT3 with tumor lower border =90 g/L, white blood cells >=3.5×10?/L Neutrophils >=1.5×10?/L, platelets >=100×10?/L Creatinine <=1.5×ULN (upper limit of normal), BUN <=1.5×ULN ALT <=2.5×ULN, AST <=2.5×ULN ALP <=1.5×ULN, total bilirubin <=1.5×ULN Urinalysis showing negative proteinuria; normal coagulation profile. 8. No history of 5-Fu or platinum-based drug allergies. 9. No prior surgery (except palliative colostomy), chemotherapy, or other antitumor therapies since initial diagnosis of primary rectal cancer. 10. No prior radiotherapy to the intended treatment field. 11. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4 immunotherapies, or other investigational immune-modulating agents. 2. History of severe autoimmune diseases, including: Active inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) Rheumatoid arthritis, scleroderma, systemic lupus erythematosus Autoimmune vasculitis (e.g., granulomatosis with polyangiitis). 3. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis. 4. Risk factors for intestinal perforation, including: Active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction Abdominal carcinomatosis, or other known intestinal perforation risks. 5. History of other malignancies, except cured non-melanoma skin cancer or cervical carcinoma in situ. 6. Active infections, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmias. 7. Physical or laboratory findings deemed by investigators to interfere with outcomes, increase treatment risks, or indicate uncontrolled comorbidities. 8. Breastfeeding or pregnant women. 9. Congenital or acquired immunodeficiency diseases (e.g., HIV), or history of organ/allogeneic stem cell transplantation. 10. Active HBV hepatitis (HBV-DNA >=2000 U/mL), HCV hepatitis, or active tuberculosis infection. 11. Prior tumor vaccination or receipt of any vaccine within 4 weeks before treatment initiation. (Note: Inactivated seasonal influenza vaccines are permitted; intranasal live attenuated vaccines are prohibited.); 12. Concurrent use of immunosuppressants, chemotherapeutics, investigational drugs, or long-term corticosteroid therapy. 13. Patients with psychiatric disorders, substance abuse, or social circumstances compromising compliance, as assessed by physicians. 14. Allergy or contraindications to study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term effect;TRG grade;Perioperative complications;AE rate;organ preservation;Tumor downstaging rate;QOL;irAE rate; | — |
Countries
China
Contacts
Public ContactJing Jin
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed