Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer (NCT07503639) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
134 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. KPS ≥ 70;
✓. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
✓. With good compliance and signed the consent form.
Exclusion criteria
✕. Pregnancy or breast-feeding women;
✕. Known history of other malignancies within 5 years;
What they're measuring
1
Complete response (CR) rate: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.
Timeframe: 1 month after the surgery or 1 year after the decision of W&W.
✕. 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;
✕. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
✕. Uncontrolled infection which needs systemic therapy;
✕. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
✕. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;