- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06210971
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
January 7, 2024 updated by: Hebei Medical University Fourth Hospital
Exploratory Study on 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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linlin Xiao, Ms.
- Phone Number: 18533167355
- Email: drxiaolinlin@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposomal irinotecan-based TNT therapy
Concurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m^2 bid + Liposomal irinotecan 50mg/m^2) followed by Chemotherapy (Capecitabine 1000mg/m^2 bid d1-7 + Liposomal irinotecan 70mg/m^2 or 50mg/m^2, d1, Q2W) before surgery.
|
Liposomal irinotecan: 50mg/m^2 or 70mg/m^2
Other Names:
Capecitabine: 625mg/m^2 or 1000mg/m^2 bid.
Other Names:
50.4Gy/28 fractions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Complete Response
Time Frame: 5 months
|
Defined as the proportion of patients who have achieved pathologic complete response.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: 4 months
|
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
|
4 months
|
Incidence of adverse events
Time Frame: 7 months
|
Use NCI-CTCAE version 5.0 for classification and grading.
|
7 months
|
Major Pathologic Response
Time Frame: 5 months
|
Defined as the proportion of patients who have achieved major pathologic response
|
5 months
|
Anal Sphincter Retention Rate
Time Frame: 5 months
|
Defined as the proportion of patients who retain anal sphincter
|
5 months
|
R0 resection rate
Time Frame: 5 months
|
Defined as the proportion of patients who have achieved R0 resection.
|
5 months
|
3-year Local Recurrence Free Survival Rate
Time Frame: 3 years
|
Defined as the proportion of patients who are not local recurrence or death at 3 years after enrollment.
|
3 years
|
3-year Progress Free Survival Rate
Time Frame: 3 years
|
Defined as the proportion of patients who are not progress or death at 3 years after enrollment.
|
3 years
|
3-year Overall Survival Rate
Time Frame: 3 years
|
Defined as the proportion of patients who are alive at 3 years after enrollment.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fengpeng Wu, Professor, The Fourth Hospital of Hebei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
January 7, 2024
First Submitted That Met QC Criteria
January 7, 2024
First Posted (Estimated)
January 18, 2024
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 7, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Irinotecan
Other Study ID Numbers
- CSPC-DEY-CRC-K08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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