Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
ConditionLocally Advanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years old, female and male;
Pathological confirmed adenocarcinoma;
Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;
Treatment-naïve and no distance metastases;
Disqualifiers
Pregnancy or breast-feeding women;
Known history of other malignancies within 5 years;
Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
Trial design
Treatments tested in this trial
- SHR-1701
- SHR-8068
- Short-course radiotherapy
- XELOX (Capecitabine and Oxaliplatin)
- PD-L1 antibody
- cetuximab β
- HRS-7058
- HRS-4642
Treatment groups
134 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov