Immunotherapy (Toripalimab) for Colon Cancer After Surgery
This study is testing if an immunotherapy drug called toripalimab can help reduce the chance of colon cancer coming back after surgery. It's for people with stage IIB, IIC, or III colon cancer that has a specific genetic feature called 'mismatch repair deficiency' (dMMR) or 'microsatellite instability-high' (MSI-H). Researchers want to see how many people are still cancer-free three years after treatment. You would receive toripalimab intravenously (through a vein) every three weeks for six months. The study will also look at side effects, long-term survival, and how the treatment affects your quality of life. About 40 people are expected to join this study, which is currently unclear if it's recruiting.
- Study design
- This is an interventional study, not specifying a phase, and plans to enroll 40 participants. It is testing the efficacy of adjuvant toripalimab.
- What's involved
- You would receive toripalimab intravenously every 3 weeks for 6 months (8 doses). After treatment, you will have follow-up visits every 6 months for up to 5 years, including blood tests, CT scans, and colonoscopies.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up every 6 months until 5 years post-resection after completing study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07140679
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentEmory UniversityInvestigator-initiated
~40 participants
Updated 2025-09-25 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionColonoscopyComputed TomographyQuestionnaire AdministrationToripalimab
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3-year Disease free survival (DFS)
Measured over Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years
Conditions
Where it's being run
5 sites across 1 statesGeorgia5
Study leadership
- Oluwadunni E. Emiloju, MBBS, MS · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \[AJCC\] 8)
Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)
Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug
Available tissue sample from surgical specimen
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Absolute neutrophil count (ANC) ≥ 1,500 /mcL
Platelets ≥ 100,000 / mcL
Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L
Transfusion is allowed to obtain an adequate hemoglobin level
Creatinine ≤ 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 40 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
Creatinine clearance should be calculated per institutional standard
Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 x ULN
Patients with previously diagnosed Gilbert syndrome can have total bilirubin \< 3.0 mg/dL
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
Alkaline phosphatase ≤ 2.5 x ULN
Signed informed consent
Patients at least 18 years of age
Must have had a full colonoscopy prior to enrollment. If synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible
Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP are women younger than 55 years (yrs) of age excluding those who are surgically unable to get pregnant due to prior hysterectomy and or bilateral salpingo-oophorectomy
Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 90 days after the last dose of study drug. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard
Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of study drug
Exclusion
Neoadjuvant treatment for dMMR colon cancer
Presence of metastatic dMMR colon cancer
Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule
History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease
History of a hematologic or primary solid tumor malignancy within the last 5 years
Autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, diabetes mellitus type 1, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, controlled psoriasis or resolved childhood asthma/atopy not requiring systemic treatment can be enrolled
Active hepatitis B or hepatitis C
Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, nasal seasonal flu, H1N1 flu, rabies, Bacille Calmette Guerin (BCG) and typhoid vaccine
Prior treatment with any immune checkpoint inhibitor
Current pregnancy or breastfeeding
What this trial measures
- 3-year Disease free survival (DFS)Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 3 years