Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression
Status:
NOT_YET_RECRUITING
Trial end date:
2030-11-01
Target enrollment:
Participant gender:
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 (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/m via 180-minute intravenous infusion on Day 1.
Leucovorin: 400 mg/m via 120-minute intravenous infusion on Day 1.
5-Fluorouracil: 2400 mg/m 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).
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Patients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.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 + Alvenor) are determined by the investigator.
Control Group Restriction: Patients in the control arm are not permitted to self-administer citrus flavonoid tablets (Alvenor) during the trial. Any requirement for this medication must be discussed with the treating physician, who will decide on alternative therapies or trial withdrawal.