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Not yet recruiting NCT07403877

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

Phase II Interventional Colorectal Cancer (MSI-H)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab, Ipilimumab (1mg/kg), PULSAR, Radical surgery.
Who it may be relevant to
Registry conditions: Colorectal Cancer (MSI-H). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase II Randomized Controlled Trial of Neoadjuvant Immunotherapy With or Without Radiotherapy in Locally Advanced Microsatellite Instability-High/Mismatch Repair-Deficient Colorectal Cancer

Overview

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.

Interventions

  • Drug Nivolumab
    Nivolumab 240 mg every 2 weeks
  • Drug Ipilimumab (1mg/kg)
    Ipilimumab 1 mg/kg every 3 weeks
  • Radiation PULSAR
    Irradiation targeted to the primary lesion (5 Gy per fraction, total 4 fractions, delivered every 3 weeks).
  • Procedure Radical surgery
    Surgical resection will be performed in resectable cases.
  • Other Watch & wait
    For patients with low rectal cancer who are unable to preserve the anal sphincter, a watch-and-wait (WW) strategy can be considered if a clinical complete response (CR) is achieved.

Primary outcome measures

  • Complete regression (CR) rate [Time frame: 1 month after surgery or the completion of neoadjuvant therapy]
Secondary outcome measures (7)
  • R0 resection rate [Time frame: 1 month after surgery]
  • Objective response rate (ORR) [Time frame: 6 months after the enrollment of the last subject]
  • Event-free survival (EFS) [Time frame: 36 months after the enrollment of the last subject]
  • Overall survival (OS) [Time frame: 36 months after the enrollment of the last subject]
  • Toxicities [Time frame: From the time of enrollment, assessed up to 28 days after the last dose of study therapy]
  • Surgical morbidity [Time frame: During or one month after surgery]
  • Surgical mortality [Time frame: During or one month after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07403877 · FDRT-2025-592-4741

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗