Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (MSI-H) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab (1mg/kg) | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| PULSAR | Radiation | — | UNRESOLVED |
| Radical surgery | Procedure | — | UNRESOLVED |
| Watch & wait | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- anti-PD-1 plus anti-CTLA-4
- description
- Arm A: Nivolumab 240 mg every 2 weeks (6 doses) plus ipilimumab 1 mg/kg every 3 weeks (4 doses).
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab (1mg/kg)
- Procedure: Radical surgery
- Other: Watch & wait
- type
- EXPERIMENTAL
- label
- anti-PD-1 plus radiotherapy
- description
- Arm B: Radiotherapy (5 Gy per fraction, total 4 fractions, delivered every 3 weeks) to the primary lesion plus nivolumab 240 mg every 2 weeks (6 doses).
- interventionNames
- Drug: Nivolumab
- Radiation: PULSAR
- Procedure: Radical surgery
- Other: Watch & wait
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed primary colorectal adenocarcinoma. 2. Radiographic assessment showed a stage II-III based on AJCC Stage 8th ed. 3. At least 18 years old. 4. MSI-H or dMMR. 5. The Eastern Cooperative Oncology Group performance status (ECOG PS) score is 0 or 1. 6. Physical state or organ function can tolerate the planned treatment of the study protocol. 7. Agreed to sign written informed consent before recruitment. Exclusion Criteria: 1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. Pregnancy or breastfeeding women. 3. History of other malignancies within 5 years. 4. Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 5. Immunodeficiency disease or long-term using of immunosuppressive agents. 6. Allergic to any component of the therapy. 7. Any other condition or disease that is not suitable to take the therapy included in the protocol. 8. 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. 9. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
References
Publications (0)
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