Immunotherapy after surgery may keep colon cancer from returning
NCT ID NCT07140679
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests whether the immunotherapy drug toripalimab can lower the chance of cancer coming back after surgery in people with mismatch repair deficient (dMMR) stage IIB, IIC, or III colon cancer. About 40 participants will receive toripalimab intravenously. The study will track how many remain cancer-free after three years and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (an immunotherapy drug)
- What this could lead to
- If successful, this could offer a new way to prevent colon cancer from coming back after surgery for people with a specific genetic feature.
- What could go wrong
- This is a small, early-phase trial with only 40 people, so results may not apply to everyone. Immunotherapy can cause side effects like inflammation in healthy organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Decatur Hospital
RECRUITINGAtlanta, Georgia, 30033, United States
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Emory Johns Creek Hospital
RECRUITINGJohns Creek, Georgia, 30097, United States
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Emory Saint Joseph's Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New combo immunotherapy aims to shrink colon tumors before surgery
- New app aims to help cancer survivors and families stick to healthy habits
- New antibody shows promise in shrinking HER2+ colorectal tumors before surgery
- New cocktail shows promise for Tough-to-Treat colorectal cancer
- New drug cocktail aims to stop BRAF colon cancer in its tracks
- New combo therapy targets hard-to-treat colorectal cancer