UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Status Recruiting

Clinical Trial Summary

To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world.

Clinical Trial Description

Neoadjuvant chemoradiotherapy (nCRT) combined with surgery is the standard care of treatment for locally advanced rectal cancer (LARC), which could effectively reduce the risk of local recurrence, increase the chance of sphincter preservation, and effectively improve the quality of life of patients. However, only about 8% of patients can benefit from nCRT. Therefore, to improve the therapeutic effect of nCRT and retain the organ function of patients so as to improve their quality of life is the focus of the current investigation. In the previous study, the investigator have completed a series of clinical researches of irinotecan guided by UGT1A1 gene for nCRT in rectal cancer. A dose climbing study was firstly conducted to explore the maximum tolerable dose of irinotecan for nCRT in rectal cancer. The results indicated that the weekly dose intensity of irinotecan could be increased from 50mg/m2 to 80mg/m2 when the genotype of UGT1A1*28 locus was 6/6, and the weekly dose intensity of irinotecan could also reach 65mg/m2 when the genotype of irinotecan was 6/7 phenotype. Further analysis also demonstrated that there was a dose-effect relationship between the total dose of irinotecan and pathological complete remission (pCR). The recently published CinClare study is a 3-phase randomized controlled trial that doubles the pCR rate and the total CR rate in combination with irinotecan on the basis of capecitabine combined with radiotherapy. However, in the Aristotle study conducted in the United Kingdom at the same phase, it has not been proved that irinotecan could improve the pCR rate, and it is not known whether the difference between the two studies is completely attributed to the irinotecan dose. Therefore, the investigator designed this real-world study to explore whether irinotecan can indeed improve the treatment efficacy in the real world when using irinotecan under the guidance of UGT1A1 gene in nCRT for LARC. Any locally advanced rectal cancer patients treated with irinotecan-based neoadjuvant radiotherapy and chemotherapy can be enrolled in this study. It is expected that the results of this study could provide more basis for individualized treatment of LARC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05148767
Study type	Interventional
Source	Zhejiang Cancer Hospital
Contact	Ji Zhu, MD
Phone	571-88128142
Email	leo.zhu@126.com
Status	Recruiting
Phase	Phase 4
Start date	January 1, 2022
Completion date	December 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05495308` - "Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".
Recruiting	`NCT04598984` - The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
Active, not recruiting	`NCT04246684` - Short RT Versus RCT,Followed by Chemo.and Organ Preservation for Interm and High-risk Rectal Cancer Patients	Phase 3
Completed	`NCT05723965` - Using Artificial Intelligence to Predict Rectal Cancer Outcomes
Not yet recruiting	`NCT05830890` - Sentinel Lymph Node Biopsy in Rectal Cancer	N/A
Recruiting	`NCT04503694` - Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer	Phase 2
Completed	`NCT02363374` - Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer	Phase 2
Recruiting	`NCT03561142` - Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.	Phase 2
Completed	`NCT03602079` - Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene	Phase 1/Phase 2
Recruiting	`NCT06254521` - The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer	Phase 2
Completed	`NCT01325649` - Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma	N/A
Recruiting	`NCT04970498` - Application of MRI in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer
Active, not recruiting	`NCT03840239` - TNT to Increase the Clinical Complete Response Rate for Distal LARC	Phase 2
Active, not recruiting	`NCT03391843` - Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.