Actively Recruiting
A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency
Led by Emory University · Updated on 2025-09-25
40
Participants Needed
5
Research Sites
13 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
Researchers are evaluating the use of immunotherapy with toripalimab to reduce the risk of cancer returning after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer. This phase II trial aims to measure how well toripalimab works by assessing disease-free survival over three years and other long-term outcomes, including relapse-free survival and overall survival. The study also focuses on understanding immune-related side effects and exploring biological markers linked to treatment response and patient quality of life. Participants will receive toripalimab through intravenous infusions every three weeks for six months, totaling eight doses, provided the disease does not return and side effects remain acceptable. After finishing the treatment phase, patients will be monitored regularly with blood tests, CT scans, and colonoscopies at specific intervals for up to five years after surgery. In cases where cancer recurrence occurs, a biopsy will be performed to gather additional information. During the study, participants will complete questionnaires to report on their health and quality of life. Researchers will track disease status through imaging and laboratory assessments, and monitor for any treatment-related adverse events for up to five years. This comprehensive follow-up ensures careful observation of long-term outcomes and safety. The total participation duration may last up to five years post-surgery, including treatment and surveillance periods.
CONDITIONS
Brief 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, or III mismatch repair deficient colon cancer
- Deficient mismatch repair confirmed by immunohistochemistry, PCR, or next generation sequencing
- Complete tumor removal (R0 resection) 4 to 12 weeks before first dose
- Available tissue sample from surgical specimen
- ECOG performance status 0, 1, or 2
- Absolute neutrophil count of at least 1,500/mcL
- Platelet count of at least 100,000/mcL
- Hemoglobin level of at least 9 g/dL (transfusion allowed to meet this)
- Creatinine level less than or equal to 1.5 times upper limit of normal or creatinine clearance of at least 40 mL/min
- Total bilirubin less than or equal to 1.5 times upper limit of normal (with exceptions for Gilbert syndrome)
- AST and ALT levels less than or equal to 2.5 times upper limit of normal
- Alkaline phosphatase less than or equal to 2.5 times upper limit of normal
- Signed informed consent
- Age 18 years or older
- Full colonoscopy completed before enrollment with all synchronous cancers having deficient mismatch repair and complete resection
- Women of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Use of effective birth control during treatment and 90 days after last dose
- Breastfeeding women must stop nursing before first dose and during study treatment
You will not qualify if you...
- Prior neoadjuvant treatment for mismatch repair deficient colon cancer
- Presence of metastatic mismatch repair deficient colon cancer
- Medical conditions that may make study drug unsafe or confound adverse event interpretation
- Uncontrolled psychiatric illness or psychological conditions affecting study compliance
- History of pneumonitis requiring steroids or interstitial lung disease
- History of hematologic or primary solid tumor cancer within 5 years
- Autoimmune diseases requiring systemic treatment in past 2 years, with some exceptions
- Active hepatitis B or C infection
- Immunosuppressive therapy or systemic steroids within 7 days before first dose
- Live vaccines within 30 days before first dose
- Prior treatment with immune checkpoint inhibitors
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months
Participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity.
Approximately 8 visits every 3 weeks for infusions
Duration - Up to 5 years post-resection
After treatment completion, participants undergo surveillance follow-up with blood tests, CT scans, and colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life are also assessed with questionnaires.
Visits every 6 months for assessments including blood tests, CT scans, and colonoscopy at specified intervals
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
O
Olatunji B. Alese, MD, FASCO
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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