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Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
Sponsor: Fudan University
Summary
This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.
Official title: An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2026-04
Completion Date
2030-04
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
SHR-1701
1800mg d1 q3w
SHR-8068
280mg,C1D1
Short-course radiotherapy
25Gy/5Fx
XELOX (Capecitabine and Oxaliplatin)
Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w
PD-L1 antibody
1200mg d1 q3w
cetuximab β
250mg/m2 d1, 500mg/m2 d8 q3w
HRS-7058
200mg bid
HRS-4642
500mg d1, 1200mg d8 q3w