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NOT YET RECRUITING
NCT07817888
PHASE2

mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: Neoadjuvant mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer: A Singe-arm Phase II Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2026-09-30

Completion Date

2031-09-30

Last Updated

2026-09-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

FOLFOXIRI + Bevacizumab

Oxaliplatin 85 mg/m² intravenous infusion over 180 minutes on day 1; irinotecan 150 mg/m² intravenous infusion over 90 minutes on day 1; leucovorin 400 mg/m² intravenous infusion over 120 minutes on day 1; 5-fluorouracil 2400 mg/m² continuous intravenous infusion over 46 hours; bevacizumab 5 mg/kg intravenous infusion over 30-90 minutes on day 1.