Actively Recruiting
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
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-05-26
236
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
G
Guangzhou First People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter, open-label, randomized controlled Phase II clinical trial for patients with locally advanced rectal cancer who test positive for high YWHAB expression before surgery. The trial aims to evaluate the effectiveness and safety of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimailang) as a neoadjuvant (preoperative) treatment, building on previous research and safety data. Participants will receive 4 to 6 cycles of neoadjuvant therapy before surgery, with each cycle lasting 14 days. The mFOLFOX regimen includes oxaliplatin, leucovorin, and 5-fluorouracil administered intravenously on Day 1, while citrus flavonoid tablets (Aimailang) are taken orally twice daily for 14 days. Patients are randomly assigned to either mFOLFOX alone or mFOLFOX combined with Aimailang. Dose adjustments are allowed based on tolerance, and treatment may stop early for disease progression or intolerance, with surgery following. During the study, participants will undergo tumor assessments and surgery after completing neoadjuvant therapy. Researchers will evaluate outcomes such as tumor downstaging rate, tumor regression grade, disease-free survival, overall survival, and treatment-related adverse events. Safety and response rates will be monitored up to five years. Participants must comply with scheduled visits, treatment, laboratory tests, and other study procedures throughout the trial.
CONDITIONS
Brief Title
Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed rectal adenocarcinoma; other histologic subtypes excluded
- Measurable or clinically evaluable rectal tumor at clinical stage T2N+ or T3-4aAnyN, M0
- Pelvic MRI confirms tumor not adherent to mesorectal fascia (distance 2 mm)
- High YWHAB expression confirmed by immunohistochemistry
- Age 18 to 75 years at consent
- ECOG performance status 0 or 1
- No prior systemic anticancer therapy for rectal cancer
- Adequate organ function with specified blood count and liver/kidney test levels
- Females of childbearing potential must have negative pregnancy test and use contraception
- Male patients with partners of childbearing potential must use effective contraception
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Rectal cancer histologic subtypes other than adenocarcinoma
- Tumor adherent to mesorectal fascia (tumor-MRF distance < 2 mm)
- Prior systemic anticancer therapy for rectal cancer
- Inadequate organ function outside specified laboratory parameters
- Females who are pregnant or breastfeeding
- Inability or unwillingness to comply with study visits or treatments
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 cycles of 14 days each
Participants receive neoadjuvant therapy consisting of 4 to 6 cycles of mFOLFOX chemotherapy, with or without citrus flavonoid tablets (Aimailor), administered in 14-day cycles before surgery.
4 to 6 visits for chemotherapy administration
Duration - 1 day
Participants undergo tumor resection surgery performed by a specialized colorectal surgical team after completing neoadjuvant therapy.
1 visit (in-person surgery)
Duration - 6 to 8 cycles of 14 days each
Participants receive postoperative adjuvant therapy consisting of 6 to 8 cycles of mFOLFOX chemotherapy, with or without citrus flavonoid tablets, in 14-day cycles.
6 to 8 visits for chemotherapy administration
Duration - Up to 5 years
Participants are monitored for treatment outcomes including tumor response and survival during follow-up assessments.
Periodic visits over several years for assessments
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
T
Tuo Hu, M.D./Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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