Status:
NOT_YET_RECRUITING
Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Rectal Cancer Patients
Rectal Cancer Stage II
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a prospective, open-label, two-arm, phase II clinical trial involving patients preoperatively diagnosed with YWHAB (Tyrosine 3-monooxygenase/tryptophan 5-monooxygenase activation protein...
Detailed Description
This study plans to conduct a prospective, open-label, two-arm, phase II clinical trial: For patients with locally advanced rectal cancer, YWHAB immunohistochemical staining will be performed on endos...
Eligibility Criteria
Inclusion
- Histopathologically confirmed rectal adenocarcinoma: All other histological types are excluded. The patients have concurrent hemorrhoids documented by colonoscopy report or clinical physical examination.
- Clinical Pathological Stage: Tumor staged as T3-4 or N+, M0 (according to the AJCC （American Joint Committee on Cancer）TNM （Tumor-Node-Metastasis) Staging System, 9th Edition; see Appendix 1).
- Biomarker Status: Immunohistochemical staining of the tissue specimen demonstrates high expression of YWHAB in rectal cancer.
- Age: 18 to 75 years old, inclusive, at the time of signing the Informed Consent Form (ICF).
- Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 3).
- Prior Therapy: No prior systemic anti-tumor therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.
- Adequate Organ Function: Based on laboratory values obtained during the screening period:White Blood Cell (WBC) count ≥ 3.0 × 10⁹/L, absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 75 × 10⁹/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.
- 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.
- 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.
- 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
- Distant Metastasis: Confirmed by systemic imaging (CT（Computed Tomography）, MR （Magnetic Resonance Imaging）, or PET-CT （Positron Emission Tomography - Computed Tomography）) encompassing at least the chest, abdomen, and pelvis.
- Pharmacogenetic Deficiency: Known complete DPD (dihydropyrimidine dehydrogenase) enzyme deficiency or homozygous UGT1A1\*28 (7/7) genotype identified by whole-genome testing.
- Acute Surgical Complications: Presence of complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- 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).
- 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.
- Significant Cardiac Disease: Occurrence of any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, heart failure of NYHA （New York Heart Association Functional Classification）class 2 or higher, clinically significant supraventricular or ventricular arrhythmia requiring treatment, or symptomatic congestive heart failure.
- 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).
- 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.
- HIV/AIDS: Known HIV (Human Immunodeficiency Virus) infection or AIDS (Acquired Immunodeficiency Syndrome)-related illness.
- 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).
- Untreated Active Hepatitis: Untreated active hepatitis B virus (defined as HBV-DNA ≥ 500 IU/mL) or hepatitis C virus (defined as HCV-RNA above the lower limit of quantification), or known co-infection with HBV and HCV.
- Drug Hypersensitivity: Known or suspected history of hypersensitivity to any of the drugs related to the study treatment.
- Investigator Discretion: Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in the study.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT07176182
Start Date
November 1 2025
End Date
November 1 2030
Last Update
September 16 2025
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655