Phase II Study of mFOLFOX Chemotherapy With or Without Citrus Flavonoid Tablets Aimailang as Pre-Surgery Treatment for Locally Advanced Rectal Cancer With High YWHAB Expression

What this Trial Is About

Researchers are conducting a prospective, multicenter, open-label, randomized controlled Phase II clinical trial for patients with locally advanced rectal cancer who test positive for high YWHAB expression before surgery. The trial aims to evaluate the effectiveness and safety of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets Aimailang as a neoadjuvant preoperative treatment, building on previous research and safety data. Participants will receive 4 to 6 cycles of neoadjuvant therapy before surgery, with each cycle lasting 14 days. The mFOLFOX regimen includes oxaliplatin, leucovorin, and 5-fluorouracil administered intravenously on Day 1, while citrus flavonoid tablets Aimailang are taken orally twice daily for 14 days. Patients are randomly assigned to either mFOLFOX alone or mFOLFOX combined with Aimailang. Dose adjustments are allowed based on tolerance, and treatment may stop early for disease progression or intolerance, with surgery following. During the study, participants will undergo tumor assessments and surgery after completing neoadjuvant therapy. Researchers will evaluate outcomes such as tumor downstaging rate, tumor regression grade, disease-free survival, overall survival, and treatment-related adverse events. Safety and response rates will be monitored up to five years. Participants must comply with scheduled visits, treatment, laboratory tests, and other study procedures throughout the trial.

Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression