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Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Locally Advanced Rectal Cancer Clinical Trial

Official title:
Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)

Clinical Trial Summary

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.

Clinical Trial Description

This study was a multicenter, single-arm, open-label clinical trial. The study included a screening period (within 21 days after signing the informed consent form to the first treatment), a treatment period (including total neoadjuvant and surgical treatment), and a follow-up period (including safety and survival follow-up). Total neoadjuvant therapy: - Short-course radiotherapy followed by 6 cycles of fuquinitinib combined with adbelimumab and CAPOX followed by surgical resection after 1 week of rest; - A treatment time window of ±3 days was allowed during the study treatment, but within 3 days before each treatment, in addition to the required imaging examinations, participants were required to complete laboratory tests, physical examinations (as needed), ECOG scores and other safety assessments to determine that they could still tolerate the study treatment. The safety of the subjects was continuously assessed during the study. - Total Mesorectal Excision (TME) is recommended for radical resection of rectal cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06234007
Study type Interventional
Source Wuhan Union Hospital, China
Contact zhenyu Lin, Ph.D
Phone +8615827130393
Email whxhlzy@hust.edu.cn
Status Recruiting
Phase Phase 2
Start date December 1, 2023
Completion date December 31, 2027
View Details
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