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.
Sign the informed consent form and comply with the planned visits, study treatment, laboratory tests, and other trial procedures;
Age 18-75 years;
Histologically confirmed rectal adenocarcinoma;
The lower edge of the rectal tumor is <10 cm from the anal verge (as assessed by pelvic MRI);
Distant metastasis (M1) confirmed by chest/abdominal/pelvic CT, pelvic MRI, or PET-CT;
Bowel obstruction, active gastrointestinal bleeding, or perforation caused by the tumor;
Tumor complicated by intestinal fistula or pelvic abscess;
Concurrent malignant tumors of other organ systems (except malignancies that have been curatively treated with no recurrence for more than 5 years, or carcinoma in situ that can be cured by adequate treatment);
Single group
FOLFOXIRI + Bevacizumab
DrugOxaliplatin 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.
3-year Disease Free Survival
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This trial is not recruiting at the moment. You can still explore other options:
