Rectal Cancer PatientsPhase 2NCT07176182
Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression
A Phase 2 study testing mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group and mFOLFOX regimen neoadjuvant therapy group in people with Rectal Cancer Patients and Rectal Cancer Stage II, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Patients, Rectal Cancer Stage II, Rectal Cancer Stage III
- What is being tested?
- mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group and mFOLFOX regimen neoadjuvant therapy group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 20 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.
- 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).
- 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).
- ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.
- Age 18-75 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3).
Show all 17Show fewer
- No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy.
- 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
- 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.
- Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Tuo Hu, M.D./Ph.D, +86 137 6338 5541, hutuo3@mail.sysu.edu.cn
About this study
Official title: 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
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.
Read more
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 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.
Read the detailed description
This study plans to conduct a prospective, multicenter, open-label, randomized controlled Phase II clinical trial: Endoscopic biopsy specimens from patients with locally advanced rectal cancer will undergo YWHAB immunohistochemical staining to identify those with high YWHAB expression. These patients will be randomly assigned to receive neoadjuvant therapy with either mFOLFOX alone or mFOLFOX combined with citrus flavonoid tablets (Aimailang). Following completion of 4-6 cycles of neoadjuvant chemotherapy, patients will undergo preoperative assessment by the attending physician and tumor resection performed by a specialized colorectal surgical team. This study aims to evaluate the efficacy (tumor downstaging rate, 3-year disease-free survival, overall survival, tumor regression grade [TRG], etc.) and safety (drug-related adverse reactions, etc.) of mFOLFOX combined with citrus flavonoid tablets (Aimailang) neoadjuvant therapy in patients with locally advanced rectal cancer exhibiting high YWHAB expression. Building upon the team's prior basic/translational research, animal studies, and clinical safety data for citrus flavonoid tablets (Aimailang), this study holds promise to enhance treatment outcomes for patients with locally advanced rectal cancer exhibiting high YWHAB expression, thereby benefiting a greater number of patients.
- Being tested
- mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group, mFOLFOX regimen neoadjuvant therapy group
- Keywords
- Neoadjuvant Therapy, mFOLFOX6, Citrus Flavonoid Tablets (Aimailang)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment groupDrug
Also called 5-Fluorouracil, Oxaliplatin, Citrus Flavone Tablets (Alvenor)
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/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 (Alvenor) : 500 mg orally three times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).
mFOLFOX regimen neoadjuvant therapy groupDrug
Also called 5-Fluorouracil, Oxaliplatin
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/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.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX regimen neoadjuvant therapy group | Active comparator | Trial Group Description: This trial evaluates the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimailang) for neoadjuvant therapy (preoperative). Treatment regimen (4-6 cycles preoperatively): Each 14-day cycle includes: Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, over 180 minutes Calcium folinic acid: 400 mg/m² intravenous infusion on Day 1, over 120 minutes Fluorouracil: 2400 mg/m² continuous intravenous infusion on Day 1, over 46 hours Receives: Drug: mFOLFOX regimen neoadjuvant therapy group |
| mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group | Experimental | This trial evaluated a combination regimen of mFOLFOX chemotherapy with citrus flavonoid tablets (Aimailang) for both neoadjuvant (preoperative) and postoperative adjuvant treatment.
Treatment Regimen Preoperative (4-6 cycles), each 14-day cycle included.
Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, administered over 180 minutes.
Calcium folinic acid: 400 mg/m² intravenous infusion on Day 1, over 120 minutes.
5-Fluorouracil: 2400 mg/m², continuous intravenous infusion over 46 hours on Day 1.
Citrus Flavonoid Tablets (Aimailang): 500 mg, orally twice daily (Days 1-14), may be used in combination with the chemotherapy regimen or alone (depending on grouping). Receives: Drug: mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor downstaging rate (to ypTNM stage 0-I)
The proportion of patients with locally advanced rectal cancer who, after receiving neoadjuvant chemotherapy with mFOLFOX or mFOLFOX plus Citrus flavonoid tablets (Aimailang), were downstaged to ypTNM stage 0-I based on postoperative surgical specimens.
Measured: Perioperative，2 weeks after surgery
Secondary outcomes (8)
Three-year disease-free survival
Disease-free survival (DFS) was defined as the proportion of patients who, from the time of randomization until the end of year 3, did not experience any of the following events: disease progression; macroscopic or microscopic residual tumor after surgery; local recurrence; distant metastasis; or death from any cause, whichever occurred first.
Measured: through study completion, an average of 3 year
Overall survival
Overall survival (OS) was defined as the time from randomization to death from any cause.
Measured: through study completion, an average of 5 year
tumor regression grade (TRG)
TRG 0 indicates no residual tumor cells; TRG 1 indicates single cells or small groups of cells; TRG 2 indicates residual cancer with a desmoplastic response; and TRG 3 indicates minimal evidence of tumor response.
Measured: Perioperative，2 weeks after surgery
Rate of Treatment-Related Adverse Events (Grade 3 or Higher)
Treatment-related adverse event rate (Grade ≥3): Refers to grade 3 or higher adverse drug reactions determined to be related to the investigational antineoplastic drug/treatment in clinical trials, excluding nonspecific infusion reactions.
Measured: through study completion, an average of 1 year
Complete response (CR) rate
The proportion of patients with complete response (CR) after surgery. Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Measured: Perioperative，2 weeks after surgery
Partial response (PR) rate
The proportion of patients with partial response (PR) after surgery. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Perioperative，2 weeks after surgery
Stable disease (SD) rate
The proportion of patients with stable disease (SD) after surgery. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Perioperative，2 weeks after surgery
Progressive disease (PD) rate
The proportion of patients with progressive disease (PD) after surgery. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline if that is the smallest), with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Measured: Perioperative，2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start20 Mar 2026
- Primary completion20 Mar 2031 (estimated)
- Study completion20 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial evaluated the combination regimen of mFOLFOX chemotherapy with citrus flavonoid tablets (Aimailang) for neoadjuvant (preoperative) and postoperative adjuvant treatment. Treatment Regimen Preoperative (Cycles 4-6), each 14-day cycle included. Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, over 180 minutes. Calcium folinate: 400 mg/m² IV infusion on Day 1, over 120 minutes. Fluorouracil: 2400 mg/m² IV continuous infusion on Day 1, over 46 hours. Citrus Flavonoid Tablets (Aimailang): 500 mg orally twice daily (Days 1-14), may be used in combination with the chemotherapy regimen or as monotherapy (depending on group assignment).
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Zhujiang Hospital, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial People's Hospital, Fujian Provincial Hospital, The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Xiaosheng He, M.D./Ph.D, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176182
- Sponsor's protocol ID
- E2025123
- Status last verified
- May 2026
- First submitted
- 27 Aug 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07176182
- Acronym / sponsor ID
- E2025123
- Keywords
- Neoadjuvant Therapy, mFOLFOX6, Citrus Flavonoid Tablets (Aimailang)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Zhujiang Hospital, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial People's Hospital, Fujian Provincial Hospital, The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Mar 2031 (estimated)
- Study completion
- 20 Mar 2031 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Detailed description
This study plans to conduct a prospective, multicenter, open-label, randomized controlled Phase II clinical trial: Endoscopic biopsy specimens from patients with locally advanced rectal cancer will undergo YWHAB immunohistochemical staining to identify those with high YWHAB expression. These patients will be randomly assigned to receive neoadjuvant therapy with either mFOLFOX alone or mFOLFOX combined with citrus flavonoid tablets (Aimailang). Following completion of 4-6 cycles of neoadjuvant chemotherapy, patients will undergo preoperative assessment by the attending physician and tumor resection performed by a specialized colorectal surgical team. This study aims to evaluate the efficacy (tumor downstaging rate, 3-year disease-free survival, overall survival, tumor regression grade [TRG], etc.) and safety (drug-related adverse reactions, etc.) of mFOLFOX combined with citrus flavonoid tablets (Aimailang) neoadjuvant therapy in patients with locally advanced rectal cancer exhibiting high YWHAB expression. Building upon the team's prior basic/translational research, animal studies, and clinical safety data for citrus flavonoid tablets (Aimailang), this study holds promise to enhance treatment outcomes for patients with locally advanced rectal cancer exhibiting high YWHAB expression, thereby benefiting a greater number of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial evaluated the combination regimen of mFOLFOX chemotherapy with citrus flavonoid tablets (Aimailang) for neoadjuvant (preoperative) and postoperative adjuvant treatment. Treatment Regimen Preoperative (Cycles 4-6), each 14-day cycle included. Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, over 180 minutes. Calcium folinate: 400 mg/m² IV infusion on Day 1, over 120 minutes. Fluorouracil: 2400 mg/m² IV continuous infusion on Day 1, over 46 hours. Citrus Flavonoid Tablets (Aimailang): 500 mg orally twice daily (Days 1-14), may be used in combination with the chemotherapy regimen or as monotherapy (depending on group assignment).
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX regimen neoadjuvant therapy group | Active comparator | Drug: mFOLFOX regimen neoadjuvant therapy groupTrial Group Description: This trial evaluates the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimailang) for neoadjuvant therapy (preoperative). Treatment regimen (4-6 cycles preoperatively): Each 14-day cycle includes: Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, over 180 minutes Calcium folinic acid: 400 mg/m² intravenous infusion on Day 1, over 120 minutes Fluorouracil: 2400 mg/m² continuous intravenous infusion on Day 1, over 46 hours |
| mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group | Experimental | Drug: mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment groupThis trial evaluated a combination regimen of mFOLFOX chemotherapy with citrus flavonoid tablets (Aimailang) for both neoadjuvant (preoperative) and postoperative adjuvant treatment. Treatment Regimen Preoperative (4-6 cycles), each 14-day cycle included. Oxaliplatin: 85 mg/m² intravenous infusion on Day 1, administered over 180 minutes. Calcium folinic acid: 400 mg/m² intravenous infusion on Day 1, over 120 minutes. 5-Fluorouracil: 2400 mg/m², continuous intravenous infusion over 46 hours on Day 1. Citrus Flavonoid Tablets (Aimailang): 500 mg, orally twice daily (Days 1-14), may be used in combination with the chemotherapy regimen or alone (depending on grouping). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.
- 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).
- 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).
- ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.
- Age 18-75 years at the time of informed consent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment groupAlso: 5-Fluorouracil, Oxaliplatin, Citrus Flavone Tablets (Alvenor)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/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 (Alvenor) : 500 mg orally three times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment). | Drug | mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group |
| mFOLFOX regimen neoadjuvant therapy groupAlso: 5-Fluorouracil, OxaliplatinThe 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/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. | Drug | mFOLFOX regimen neoadjuvant therapy group |
Primary outcome
Tumor downstaging rate (to ypTNM stage 0-I)
Time frame: Perioperative，2 weeks after surgery
The proportion of patients with locally advanced rectal cancer who, after receiving neoadjuvant chemotherapy with mFOLFOX or mFOLFOX plus Citrus flavonoid tablets (Aimailang), were downstaged to ypTNM stage 0-I based on postoperative surgical specimens.
8 secondary outcomes
Three-year disease-free survival
Time frame: through study completion, an average of 3 year
Overall survival
Time frame: through study completion, an average of 5 year
tumor regression grade (TRG)
Time frame: Perioperative，2 weeks after surgery
Rate of Treatment-Related Adverse Events (Grade 3 or Higher)
Time frame: through study completion, an average of 1 year
Complete response (CR) rate
Time frame: Perioperative，2 weeks after surgery
Partial response (PR) rate
Time frame: Perioperative，2 weeks after surgery
Stable disease (SD) rate
Time frame: Perioperative，2 weeks after surgery
Progressive disease (PD) rate
Time frame: Perioperative，2 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaosheng He, M.D./Ph.D principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group and mFOLFOX regimen neoadjuvant therapy group in people with Rectal Cancer Patients and Rectal Cancer Stage II, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuo Hu, M.D./Ph.D (+86 13763385541, hutuo3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor downstaging rate (to ypTNM stage 0-I) (time frame: Perioperative，2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.