NCT07503639

Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SHR-1701	1800mg d1 q3w
DRUG	SHR-8068	280mg，C1D1
RADIATION	Short-course radiotherapy	25Gy/5Fx
DRUG	XELOX (Capecitabine and Oxaliplatin)	Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w
DRUG	PD-L1 antibody	1200mg d1 q3w
DRUG	cetuximab β	250mg/m2 d1, 500mg/m2 d8 q3w
DRUG	HRS-7058	200mg bid
DRUG	HRS-4642	500mg d1, 1200mg d8 q3w

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2030-04-01
• First posted: 2026-03-31
• Last updated: 2026-03-31