NCT07176182

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

mFOLFOX6 Combined With Citrus Flavonoid Tablets (Aimailang) as Neoadjuvant Therapy for Locally Advanced Rectal Cancer With High YWHAB Expression: A Prospective, Multi-center, Open-Label, Randomized Controlled Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, two-arm, phase II clinical trial involving patients preoperatively diagnosed with YWHAB (Tyrosine 3-monooxygenase/tryptophan 5-monooxygenase activation protein beta)-high locally advanced rectal cancer. The trial evaluates a regimen combining mFOLFOX chemotherapy with citrus flavonoid tablets (Aimailang) for neoadjuvant therapy (pre-surgery) and postoperative adjuvant therapy. Treatment Protocol Preoperative (4-6 cycles) and Postoperative (6-8 cycles): Each 14-day cycle includes: 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 Patients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.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.

Detailed description

This study plans to conduct a prospective, multicenter, open-label, randomized controlled Phase II clinical trial: Endoscopic biopsy specimens from patients with locally advanced rectal cancer will undergo YWHAB immunohistochemical staining to identify those with high YWHAB expression. These patients will be randomly assigned to receive neoadjuvant therapy with either mFOLFOX alone or mFOLFOX combined with citrus flavonoid tablets (Aimailang). Following completion of 4-6 cycles of neoadjuvant chemotherapy, patients will undergo preoperative assessment by the attending physician and tumor resection performed by a specialized colorectal surgical team. This study aims to evaluate the efficacy (tumor downstaging rate, 3-year disease-free survival, overall survival, tumor regression grade \[TRG\], etc.) and safety (drug-related adverse reactions, etc.) of mFOLFOX combined with citrus flavonoid tablets (Aimailang) neoadjuvant therapy in patients with locally advanced rectal cancer exhibiting high YWHAB expression. Building upon the team's prior basic/translational research, animal studies, and clinical safety data for citrus flavonoid tablets (Aimailang), this study holds promise to enhance treatment outcomes for patients with locally advanced rectal cancer exhibiting high YWHAB expression, thereby benefiting a greater number of patients.

Conditions

• Rectal Cancer Patients
• Rectal Cancer Stage II
• Rectal Cancer Stage III

Interventions

Type	Name	Description
DRUG	mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group	The trial evaluates a regimen combining mFOLFOX chemotherapy with citrus flavonoid tablets (Alvenor) for neoadjuvant therapy (pre-surgery) and postoperative adjuvant therapy. Treatment Protocol Preoperative (4-6 cycles) and Postoperative (6-8 cycles): Each 14-day cycle includes: 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 (Alvenor) : 500 mg orally three times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).
DRUG	mFOLFOX regimen neoadjuvant therapy group	The trial evaluates a regimen combining mFOLFOX chemotherapy with citrus flavonoid tablets (Alvenor) for neoadjuvant therapy (pre-surgery) and postoperative adjuvant therapy. Treatment Protocol Preoperative (4-6 cycles) and Postoperative (6-8 cycles): Each 14-day cycle includes: 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2025-09-16
• Last updated: 2026-02-27

Locations

1 site across 1 country: China