NCT07503639Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07503639
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 134
- From Apr 2026 to the primary completion date, Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
Other illness
- 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;
- 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;
- Allergic to any component of the therapy.
Other
- Pregnancy or breast-feeding women;
Who the study is looking for
- 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;
- 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;
- With good compliance and signed the consent form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.