Actively Recruiting
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
Led by Emory University · Updated on 2025-09-25
40
Participants Needed
5
Research Sites
223 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.
CONDITIONS
Official Title
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (AJCC 8)
- Deficient mismatch repair by immunohistochemistry or microsatellite instability (MSI-H) by PCR or next generation sequencing
- Complete (R0) resection of stage IIB, IIC, or III dMMR colon cancer 4 to 12 weeks before first study drug dose
- Available tissue sample from surgical specimen
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Absolute neutrophil count 63 1,500 /mcL
- Platelets 63 100,000 / mcL
- Hemoglobin 63 9 g/dL or 63 5.0 mmol/L; transfusion allowed to meet this level
- Creatinine 64 1.5 x upper limit of normal (ULN) or creatinine clearance 63 40 mL/min if creatinine is higher
- Total bilirubin 64 1.5 x ULN or direct bilirubin 64 ULN; Gilbert syndrome patients can have total bilirubin < 3.0 mg/dL
- AST and ALT 64 2.5 x ULN
- Alkaline phosphatase 64 2.5 x ULN
- Signed informed consent
- Patients at least 18 years old
- Must have had a full colonoscopy before enrollment; if multiple colon cancers, all must be dMMR and fully resected
- Women of childbearing potential must have negative pregnancy test within 72 hours before first dose
- Patients of childbearing potential must use effective birth control during treatment and 90 days after last dose
- Breastfeeding women must stop nursing before first dose and during treatment plus 90 days after last dose
You will not qualify if you...
- Neoadjuvant treatment for dMMR colon cancer
- Metastatic dMMR colon cancer present
- Medical conditions that pose risk or make side effect interpretation difficult
- Uncontrolled psychiatric illness or psychological conditions affecting compliance
- History of pneumonitis requiring steroids or interstitial lung disease
- History of hematologic or primary solid tumor malignancy within last 5 years
- Autoimmune disease requiring systemic treatment within past 2 years (some exceptions apply)
- Active hepatitis B or C infection
- Systemic steroid or immunosuppressive therapy within 7 days before first dose
- Treatment with live vaccines within 30 days before first dose
- Prior treatment with any immune checkpoint inhibitor
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Emory Decatur Hospital
Atlanta, Georgia, United States, 30033
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Actively Recruiting
Research Team
O
Oluwadunni E. Emiloju, MBBS, MS
CONTACT
O
Olatunji B. Alese, MD, FASCO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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