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

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Patients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.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

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Guangzhou First People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Principal Investigators

• Xiaosheng He, M.D./Ph.D · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2031-03-01

Completion

2031-03-01

Countries

• China

Study Locations