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

NCT06210971 | Recruiting Phase 2 DMC

• 1 other identifier: CSPC-DEY-CRC-K08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

UGT1A1; liposomal irinotecan; total neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Defined as the proportion of patients who have achieved pathologic complete response.

  1 week after sugery

Secondary Outcomes (9)

• clinical complete response

  up to 30 weeks

• Major Pathologic Response

  1 week after sugery

• Objective Response Rate

  through study completion，an average of 3 year

• Anal Sphincter Retention Rate

  1 week after sugery

• R0 resection rate

  1 week after sugery

Study Arms (1)

Liposomal irinotecan-based TNT therapy

EXPERIMENTAL

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.

Drug: liposomal irinotecan; Drug: Capecitabine; Radiation: Radiation threapy

Interventions

liposomal irinotecan DRUG

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

Also known as: nal-IRI

Liposomal irinotecan-based TNT therapy

Capecitabine DRUG

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

Also known as: Xeloda

Liposomal irinotecan-based TNT therapy

Radiation threapy RADIATION

50.4Gy/28 fractions

Also known as: RT

Liposomal irinotecan-based TNT therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

irinotecan sucrosofate; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Fengpeng Wu, Professor

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linlin Xiao, Ms.

CONTACT

18533167355; drxiaolinlin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)