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

This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase/tryptophan 5-monooxygenase-activating protein β) prior to surgery. The trial aims to evaluate the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimilang) for neoadjuvant (preoperative) treatment.

Treatment Regimen 4-6 cycles preoperatively, with each cycle lasting 14 days.

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Oxaliplatin: 85 mg/m² via 180-minute intravenous infusion on Day 1.

Leucovorin: 400 mg/m² via 120-minute intravenous infusion on Day 1.

5-Fluorouracil: 2400 mg/m² via continuous intravenous infusion over 46 hours.

Citrus flavonoid tablets (Aimailang) : 500 mg orally twice times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).

Key Trial Design Features Dose Adjustments: Permitted during the trial based on patient tolerance.

Discontinuation Criteria:

Patients with disease progression during neoadjuvant therapy will cease study treatment and proceed to surgery or alternative therapies per local guidelines.

Surgery may be initiated early if patients cannot tolerate the planned 6 cycles of neoadjuvant therapy.

Patients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.

Postoperative Management:

Post-treatment plans (e.g., continuation of mFOLFOX + Aimailang) are determined by the investigator.

Control Group Restriction: Patients in the control arm are not permitted to self-administer citrus flavonoid tablets (Aimailang) during the trial. Any requirement for this medication must be discussed with the treating physician, who will decide on alternative therapies or trial withdrawal.