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Trial Title:
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
NCT ID:
NCT06210971
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Irinotecan
Conditions: Keywords:
UGT1A1
liposomal irinotecan
total neoadjuvant therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
liposomal irinotecan
Description:
Liposomal irinotecan: 50mg/m^2 or 70mg/m^2
Arm group label:
Liposomal irinotecan-based TNT therapy
Other name:
nal-IRI
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine: 625mg/m^2 or 1000mg/m^2 bid.
Arm group label:
Liposomal irinotecan-based TNT therapy
Other name:
Xeloda
Intervention type:
Radiation
Intervention name:
Radiation threapy
Description:
50.4Gy/28 fractions
Arm group label:
Liposomal irinotecan-based TNT therapy
Other name:
RT
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.
Criteria for 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hebei Medical University Fourth Hospital
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fengpeng Wu, Professor
Phone:
15032818011
Start date:
February 1, 2024
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06210971
