Locally advanced rectal cancer
Conditions
Interventions
Group B:Long-course radiotherapy + sequential dual immunotherapy group
Group A:Short-course radiotherapy+2 cycles of paromlimab and Tuvonralimab+2 cycles of CAPEOX/tislelizumab
Group C:Conventional Long-Course Chemoradiotherapy
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; ECOG performance status 0–1; 2. Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype; 3. Rectal MRI stage II/III (excluding T4b); distal tumor margin = 2000/µL; ?Neutrophil count >= 1500/µL; ?Platelet count >= 100×10³/µL; ?Hemoglobin >= 9.0 g/dL; ?Serum creatinine 50 mL/min (female: creatinine clearance = [140 - age (years)] × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)); male: creatinine clearance = [140 - age (years)] × body weight (kg) × 1.00 / (72 × serum creatinine (mg/dL))); ?AST <= 3×ULN, ALT <= 3×ULN, total bilirubin <= 1.5×ULN; 10. No psychiatric/psychological disorders affecting social function; 11. Negative serum pregnancy test (blood HCG) within 1 week before randomization for women of childbearing potential; 12. Women of childbearing potential must agree to use effective contraception during the study period and for 5 months after the last dose of study drug; 13. Male subjects who are sexually active with women of childbearing potential must agree to use effective contraception during the study period and for 7 months after the last dose of study drug, and must refrain from sperm donation during this period.
Exclusion criteria
Exclusion criteria: 1. Multiple primary cancers or concurrent other malignant tumors; 2. Patients requiring emergency surgery due to intestinal obstruction, intestinal perforation, gastrointestinal bleeding, etc. 3. Factors affecting oral drug absorption (e.g., inability to swallow, nausea/vomiting, diarrhea, intestinal obstruction, etc.); 4. Any uncontrolled, severe concomitant diseases; 5. Hypersensitivity to any component of the study drugs; 6. Expected survival < 5 years for any reason; 7. Planned or previous organ/bone marrow transplantation; 8. Treatment with immunosuppressants or corticosteroids within 1 month before enrollment; 9. Central nervous system disorders that may impair ability to provide informed consent or comply with study procedures, as determined by the investigator; 10. Other conditions that may prevent completion of study treatment (e.g., alcoholism, drug addiction, etc.); 11. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Event-Free Survival (EFS);Metastasis-Free Survival (MFS);Recurrence-Free Survival (RFS); | — |
Countries
China
Contacts
Public ContactYingchi Yang
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed