SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer
Short-course Neoadjuvant Radiotherapy Combined With Chemotherapy and Iparomlimab and Tuvonralimab in Microsatellite Stability (MSS) or Mismatch-repair-proficient (pMMR) Patients With Locally Advanced Rectal Cancer: A Randomized Controlled Clinical Study
First Affiliated Hospital of Zhejiang University
116 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
Summary
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.
Eligibility
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Interventions
The experimental group will receive neoadjuvant short-course radiotherapy (dose 25Gy/5f), followed by CAPEOX+Iparomlimab and Tuvonralimab (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w; Iparomlimab and Tuvonralimab 5mg/kg iv d1, q3w) for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year.
The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w) for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles.
Locations(1)
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NCT06864013