Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer

Starting soon · Phase 2

Conditions studied: Colorectal Cancer (MSI-H)

In brief

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.

Key facts

Study ID

NCT07403877

Run by

Fudan University

People needed

114

Starts

2026-02-01

Expected to finish

2034-12-31

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
• Pregnancy or breastfeeding women.
• 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.
• 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.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, China

Full record on ClinicalTrials.gov

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