Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

NCT ID: NCT06210971

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2028-07-01

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 advanced rectal cancer.

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 liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal irinotecan-based TNT therapy

Concurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m\^2 bid + Liposomal irinotecan 50mg/m\^2) followed by 4-6 cycles of Chemotherapy (Capecitabine 1000mg/m\^2 bid d1-7 + Liposomal irinotecan 70mg/m\^2 or 50mg/m\^2, d1, Q2W) before surgery.

Group Type: EXPERIMENTAL

liposomal irinotecan

Intervention Type: DRUG

Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2

Capecitabine

Intervention Type: DRUG

Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.

Radiation threapy

Intervention Type: RADIATION

50.4Gy/28 fractions

Interventions

liposomal irinotecan

Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2

Intervention Type: DRUG

Capecitabine

Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.

Intervention Type: DRUG

Radiation threapy

50.4Gy/28 fractions

Intervention Type: RADIATION

Other Intervention Names

nal-IRI; Xeloda; RT

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengpeng Wu, Professor

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Linlin Xiao, Ms.

Role: CONTACT

drxiaolinlin@163.com

18533167355

Facility Contacts

Fengpeng Wu, Professor

Role: primary

15032818011

Other Identifiers

CSPC-DEY-CRC-K08

Identifier Type: -

Identifier Source: org_study_id