Status:
RECRUITING
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advance...
Detailed Description
This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan lipos...
Eligibility Criteria
Inclusion
- Age: 18\~75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
- Histopathologically confirmed rectal adenocarcinoma.
- The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge.
- Clinical stage: T3-4NanyM0 or T1-2N+M0.
- Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hb) ≥90 g/L.
- Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL.
- Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of \*1\*1 or \*1\*28.
- Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent.
Exclusion
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV infection.
- Combined with uncontrollable systemic diseases.
- History of allergy or hypersensitivity to drug or any of their excipients.
- Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery.
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
- Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders.
- Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06210971
Start Date
February 1 2024
End Date
July 1 2028
Last Update
March 13 2025
Active Locations (1)
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1
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050000