rectal cancer
Conditions
Interventions
mFOLFOX6 regimen neoadjuvant therapy group:mFOLFOX6 regimen
mFOLFOX6 regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group:mFOLFOX6 regimen combined with Citrus Flavonoid Tablets (Alvenor)
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed rectal adenocarcinoma: All other histological types are excluded. The patient must have concurrent hemorrhoids documented by colonoscopy report or clinical physical examination; 2.Clinical Pathological Stage: Tumor staged as T3-4 or N+, M0 (according to the AJCC TNM Staging System, 9th Edition; see Appendix 1); 3.Biomarker Status: Immunohistochemical staining of the tissue specimen demonstrates high expression of YWHAB in rectal cancer; 4.Age: 18 to 75 years old, inclusive, at the time of signing the Informed Consent Form (ICF); 5.Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 3); 6.Prior Therapy: No prior systemic anti-tumor therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc; 7.Adequate Organ Function: Based on laboratory values obtained during the screening period:White Blood Cell (WBC) count >= 3.0 × 10^9/L, absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, platelet count >= 75 × 10^9/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. 8.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 be willing to use a medically approved highly effective method of contraception (e.g., intrauterine device, oral contraceptives, condoms) during the study period and for 3 months after the last dose of study drug; 9.Contraception (Males): Male subjects with partners of childbearing potential must use effective methods of contraception during the study period and for 3 months after the last dose of study drug; 10.Consent and Compliance: The subject has voluntarily agreed to participate by signing the ICF and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other trial procedures;
Exclusion criteria
Exclusion criteria: 1.Distant Metastasis: Confirmed by systemic imaging (CT, MR, or PET-CT) encompassing at least the chest, abdomen, and pelvis; 2.Pharmacogenetic Deficiency: Known complete DPD (dihydropyrimidine dehydrogenase) enzyme deficiency or homozygous UGT1A1*28 (7/7) genotype identified by whole-genome testing; 3.Acute Surgical Complications: Presence of complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery; 4.Other Active Malignancies: History or concurrent presence of other active malignancies, except for malignancies treated with curative intent with no recurrence for >5 years, or adequately treated carcinoma in situ (e.g., cervical carcinoma in situ, non-melanoma skin cancer); 5.Thromboembolic Events: History of thromboembolic events (e.g., cerebrovascular accident [including transient ischemic attack], pulmonary embolism, deep vein thrombosis) within 12 months prior to study enrollment; 6.Significant Cardiac Disease: Occurrence of any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, heart failure of NYHA class 2 or higher, clinically significant supraventricular or ventricular arrhythmia requiring treatment, or symptomatic congestive heart failure; 7.Recent Infection/Fever: Systemic antibiotic use for >=7 days within 4 weeks prior to enrollment, OR unexplained fever >38.5°C during screening or prior to the first dose (fever attributed to the tumor by the investigator is allowed); 8.Major Surgery/Trauma: Undergone major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or experienced significant trauma within 2 months prior to enrollment. The surgical incision must be fully healed before study entry; 9.HIV/AIDS: Known HIV infection or AIDS-related illness; 10.Significant Pulmonary/Systemic Disease: Presence of interstitial lung disease, non-infectious pneumonitis, OR uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonitis); 11.Untreated Active Hepatitis: Untreated active hepatitis B (defined as HBV-DNA >= 500 IU/mL) or hepatitis C (defined as HCV-RNA above the lower limit of quantification), OR known co-infection with HBV and HCV; 12.Drug Hypersensitivity: Known or suspected history of hypersensitivity to any of the drugs related to the study treatment; 13.Investigator Discretion: Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor downstaging rate (to ypTNM stage 0-I); | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of Pathological Response;Three-year disease-free survival;Overall survival;Tumor regression grade;Rate of Treatment-Related Adverse Events (Grade 3 or Higher); | — |
Countries
China
Contacts
Public ContactXiaosheng He
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed