Recruiting nowPhase 2Randomised
What this trial is trying to do
The trial asks whether adding the citrus flavonoid tablet Alvenor (Aimailang) to preoperative mFOLFOX chemotherapy can improve tumour shrinkage in locally advanced rectal cancers with high YWHAB expression. The researchers are testing four to six cycles before surgery against mFOLFOX alone.
The hope is that the combination will produce more downstaging, meaning more tumours reaching stage 0–I at surgery, than chemotherapy alone. The main measure is this downstaging rate, not longer survival or fewer treatment side effects.
Worth knowing: This is an open-label Phase 2 trial in the narrower group of patients whose tumours have high YWHAB expression, and its main endpoint is a preoperative tumour stage rather than survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07176182 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 236 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sixth Affiliated Hospital, Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group
- Drug mFOLFOX regimen neoadjuvant therapy group
What it is measuring
Tumor downstaging rate (to ypTNM stage 0-I)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase/tryptophan 5-monooxygenase-activating protein β) prior to surgery. The trial aims to evaluate the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimilang) for neoadjuvant (preoperative) treatment.
Treatment Regimen 4-6 cycles preoperatively, with each cycle lasting 14 days.
Translated with DeepL.com (free version)
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 ther…
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07176182, registered by Sixth Affiliated Hospital, Sun Yat-sen University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.