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NOT YET RECRUITING
NCT07503639
PHASE2

Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

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