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NCT07503639phase 2not yet recruiting
Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
134
Enrollment · estimated
—
Countries · 0 sites
2028-04
Primary completion
5 mo ago
Record updated
Commercial relevance
No explicit biomarker / molecular-testing language identified in the public record.
Change timeline
Signals from this trial
- New trial42/100Opportunity
New phase 2 trial NCT07503639 posted by Fudan University: "Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer".
Eligibility — raw, for validation
Inclusion Criteria: 1. Age 18-75 years old, female and male; 2. Pathological confirmed adenocarcinoma; 3. Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge; 4. Treatment-naïve and no distance metastases; 5. KPS ≥ 70; 6. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment; 7. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN; 8. With good compliance and signed the consent form. Exclusion Criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years; 3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy); 4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction; 5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment; 6. Uncontrolled infection which needs systemic therapy; 7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents; 8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection; 9. Allergic to any component of the therapy.