NCT07403877Not yet recruitingPhase 2
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
A Phase II Randomized Controlled Trial of Neoadjuvant Immunotherapy With or Without Radiotherapy in Locally Advanced Microsatellite Instability-High/Mismatch Repair-Deficient Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
This phase II clinical trial evaluates the efficacy and safety of three neoadjuvant regimens in patients with locally advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC): 1) Regimen A: Dual immune checkpoint blockade with nivolumab plus ipilimumab. 2) Regimen B: Nivolumab plus radiotherapy. 3) Regimen C: Nivolumab monotherapy. The primary objectives are to determine whether: 1) Dual immune checkpoint blockade (Regimen A) is superior to nivolumab monotherapy (Regimen C); and 2) Immunotherapy plus radiotherapy (Regimen B) is superior to nivolumab monotherapy (Regimen C). Methods: Participants will be randomized in a 1:1:1 ratio to one of the three arms. For patients with resectable tumors, surgical resection will be performed. In patients with low rectal cancer and poor prospects for sphincter preservation, a watch-and-wait (WW) strategy is an option if a clinical complete response (CR) is achieved following neoadjuvant therapy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 1 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07403877
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 114
- From 1 Feb 2026 to the primary completion date, 31 Dec 2031
- 1 site in 1 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
- Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
Other illness
- History of other malignancies within 5 years.
- Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- Immunodeficiency disease or long-term using of immunosuppressive agents.
- Allergic to any component of the therapy.
- Any other condition or disease that is not suitable to take the therapy included in the protocol.
Other
- Pregnancy or breastfeeding women.
Who the study is looking for
- Histopathologically confirmed primary colorectal adenocarcinoma.
- Radiographic assessment showed a stage II-III based on AJCC Stage 8th ed.
- At least 18 years old.
- MSI-H or dMMR.
- The Eastern Cooperative Oncology Group performance status (ECOG PS) score is 0 or 1.
- Physical state or organ function can tolerate the planned treatment of the study protocol.
- Agreed to sign written informed consent before recruitment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.