54
Participants
Start Date
May 30, 2025
Primary Completion Date
November 30, 2026
Study Completion Date
May 30, 2028
Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy
"1. Radiotherapy:~ Radiotherapy location: primary site and the corresponding draining lymph node. Radiotherapy techniques: IMRT/VMRT.~ Radiotherapy dose and fractionation pattern: conventional external irradiation, 50Gy/25 fx/5 weeks or 25Gy/5fx/1 week.~2. Chemotherapy:~Long-course radiotherapy concurrent with chemotherapy: capecitabine 825mg/m2, bid, d1-5/week.~Short-course radiotherapy without concurrent chemotherapy. Consolidation chemotherapy and immunotherapy: QL1706 (iparomlimab and tuvonralimab 5mg/kg, d1) and CAPOX (Oxaliplatin 130mg/m2, d1 + capecitabine 1000mg/m2, bid, d1-14), repeated on a 21-day cycle, for 6 cycles. 3. Surgery or watch-and-wait Total mesorectal excision (TME), or watch-and-wait (for patients with clinical complete response)."
RECRUITING
Shandong Cancer Hospital and Institute, Jinan
Shandong Cancer Hospital and Institute
OTHER