drugset / Trial / NCT05969847

Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer

NCT05969847

Phase 2 Not yet recruiting 72 enrolled 池畔
NaSingle-groupOpen-labelTreatment

Summary

Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness resection was implemented.

Timeline

Start
2023-08-15
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Envafolimab Monoclonal antibody 300 mg Subcutaneous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications