drugset / Trial / NCT07817888

mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer

NCT07817888 ↗

Phase 2 Not yet recruiting 119 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Neoadjuvant mFOLFOXIRI plus bevacizumab may achieve tumor shrinkage and reduce micrometastases, offering a radiotherapy-free organ-preservation alternative for locally advanced rectal cancer. This phase II trial will enroll patients with stage II-III rectal cancer to receive six cycles of neoadjuvant mFOLFOXIRI plus bevacizumab, followed by watch-and-wait, local excision, or total mesorectal excision based on response.

Timeline

Start
2026-09-30
Primary completion
2028-09-30
Completion
2031-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

No indication recorded.