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NOT YET RECRUITING
NCT07581626
PHASE2

Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05-01

Completion Date

2028-04-01

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

DRUG

SCRT+targeted therapy+immunotherapy+chemotherapy

SCRT: 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

Locations (1)

China PLAGH

Beijing, China