Neoadjuvant mFOLFOX with Citrus Flavonoid Tablets for YWHAB-High Locally Advanced Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized phase II trial enrolling adults with clinically confirmed locally advanced rectal cancer and high YWHAB expression. Participants are randomized to receive neoadjuvant mFOLFOX with or without citrus flavonoid tablets (Aimailang) prior to surgical resection. The regimen consists of 4–6 cycles, each 14 days long, including oxaliplatin, leucovorin, and 5-fluorouracil, with oral Aimilang given twice daily on days 1–14. Primary aims include tumor downstaging and safety, while secondary endpoints cover disease-free survival, overall survival, and tumor regression grade. The study builds on prior translational work and evaluates whether the flavonoid addition can improve outcomes for YWHAB-high cancers.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.
2. Radiographically measurable or clinically evaluable rectal tumor lesion; clinical pathologic stage T2N+ or T3-4aAnyN, M0. Clinical staging is determined by physical examination, contrast-enhanced chest and abdominopelvic CT, and pelvic MRI. For patients with MRI contraindications, staging is performed with contrast-enhanced pelvic CT plus transrectal ultrasound. Staging adheres to the 9th AJCC TNM Staging System (Appendix 1).
3. Pelvic MRI confirms the tumor is not adherent to the mesorectal fascia (MRF-negative), defined as a tumor-MRF distance ≥ 2 mm (tumor distance \< 2 mm is defined as MRF involvement).
4. ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.
5. Age 18-75 years at the time of informed consent.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3).
7. No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy.
8. Adequate organ function with screening laboratory parameters meeting the following criteria:

   * White blood cell count ≥ 3 × 10⁹/L
   * Absolute neutrophil count ≥ 1.5 × 10⁹/L
   * Platelet count ≥ 75 × 10⁹/L
   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
   * Serum creatinine ≤ 1.5 × ULN
9. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study treatment and agree to use a highly effective, medically acceptable contraceptive method (e.g., intrauterine device, combined oral contraceptives, barrier methods) throughout the study and for 3 months after the last study drug administration.
10. Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration.
11. The patient voluntarily provides written informed consent and is willing and able to comply with all scheduled study visits, treatment administration, laboratory assessments, and protocol-specified procedures.

Where it's running

• The Sixth Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xiaosheng He, M.D./Ph.D — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Tuo Hu, M.D./Ph.D
• Email: hutuo3@mail.sysu.edu.cn
• Phone: +86 13763385541

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.