Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR/MSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS/BRAF) or bevacizumab (for patients with mutant RAS/BRAF), and sintilimab in patients with high-risk LARC.
Voluntarily signed the informed consent form.
Aged 18-75 years (inclusive of 18 and 75 years).
pMMR/MSS.
Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI.
Unable to comply with the study protocol or study procedures.
Patients with contraindications to surgery.
Patients with metastatic disease or recurrent rectal cancer.
Uncontrolled active autoimmune disease or active inflammatory disease at enrollment, or receiving immunosuppressive therapy.
Single group
SCRT+targeted therapy+immunotherapy+chemotherapy
DrugSCRT: 25 Gy, 5 Gy × 5 fr. One week after completion of SCRT: 1. Patients with wild-type RAS/BRAF: mFOLFOX6: oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² IV bolus on Day 1; followed by 5-fluorouracil 2400 mg/m² continuous infusion over 46 hours, q2w; sintilimab 200 mg/m² IV infusion on Day 1, q3w; cetuximab N01 500 mg/m² IV infusion on Day 1, q2w; Combination therapy for 18 weeks (9 cycles of chemotherapy). 2. Patients with mutant RAS/BRAF: CAPOX: oxaliplatin 130 mg/m² IV ivgtt, D1; capecitabine 1000 mg/m² BID, po, D1-14, q3w, for 6 cycles; sintilimab 200 mg/m² ivgtt, D1, q3w, for 6 cycles; bevacizumab 7.5 mg/kg IV infusion on Day 1, q3w, for 5 cycles
Complete Response (CR)
CR = Pathological Complete Response (pCR) + Clinical Complete Response (cCR)
R0 resection rate
Proportion of patients achieving a margin-negative tumor removal
LER
Local Excision rate
ORR
Objective Response Rate of neoadjuvant therapy ( by RECIST 1.1)
DCR
Disease Control Rate of neoadjuvant therapy (by RECIST 1.1)
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