Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

May 30, 2028

Conditions
Rectal Malignant Neoplasms
Interventions
COMBINATION_PRODUCT

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)."

Trial Locations (1)

250000

RECRUITING

Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong Cancer Hospital and Institute

OTHER

NCT07026422 - Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT) | Biotech Hunter | Biotech Hunter