Not Yet RecruitingPhase 2

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

China236 participantsStarted 2026-03-01

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 Patients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histopathologically confirmed rectal adenocarcinoma: All other histological types are excluded. The patients have concurrent hemorrhoids documented by colonoscopy report or clinical physical examination. * Clinical Pathological Stage: Tumor staged as T3-4 or N+, M0 (according to the AJCC （American Joint Committee on Cancer）TNM （Tumor-Node-Metastasis) Staging System, 9th Edition; see Appendix 1). * Biomarker Status: Immunohistochemical staining of the tissue specimen demonstrates high expression of YWHAB in rectal cancer. * Age: 18 to 75 years old, inclusive, at the time of signing the Informed Consent Form (ICF). * Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 3). * Prior Therapy: No prior systemic anti-tumor therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc. * Adequate Organ Function: Based on laboratory values obtained during the screening period:White Blood Cell (WBC) count ≥ 3.0 × 10⁹/L, absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, serum Total Bilirubin ≤ 1.5 × Upper Normal Limit (UNL), aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 × UNL, serum Creatinine ≤ 1.5 × UNL. * Contraception (Females of Childbearing Potential - FCBP): FCBP must have a negative serum pregnancy test within 3 days prior to initiation of study treatment. They must b…

What they're measuring

Tumor downstaging rate (to ypTNM stage 0-I)

Timeframe: Perioperative，2 weeks after surgery

Trial details

NCT IDNCT07176182

SponsorSixth Affiliated Hospital, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03-01

Contact for this trial

Tuo Hu, M.D./Ph.D

+86 13763385541 hutuo3@mail.sysu.edu.cn