Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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) ≥ 1,000 /mcL
• Platelets ≥ 75,000 / 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]) ≤ 3 x ULN
• Alkaline phosphatase ≤ 3 x ULN
• Signed informed consent
• Patients at least 18 years of age
• Colonoscopy should be performed before surgery and if synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible. If colonoscopy was not done pre-operatively, the patient may still be eligible if all other inclusion criteria are met. It should however be performed within 6 months after initial colon resection surgery
• 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

You cannot join if

• 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 prior malignancy other than the cancer under study, that is progressing or has required active treatment within the past 3 years. Exceptions include adequately treated basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured.
• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

toripalimab-tpzi. A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells. PD-1, a transmembrane protein in the Ig superfamily that is expressed on activated T cells, negatively regulates T-cell activation and effector function when activated by its ligands; it plays an important role in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• Biopsy Procedure (Procedure): Undergo biopsy
• Biospecimen Collection (Procedure): Undergo collection of blood samples
• Colonoscopy (Procedure): Undergo colonoscopy
• Computed Tomography (Procedure): Undergo CT
• Questionnaire Administration (Other): Ancillary studies
• Toripalimab (Drug): Given IV

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• blood samples: Part of the study plan
• CT scans: Part of the study plan
• questionnaires: Part of the study plan
• endoscopy: Part of the study plan
• surgery: Part of the study plan

Main goals

• 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)

Other goals

• Incidence of treatment-related adverse events
• 3-year Relapse free survival (RFS)
• 5-year DFS
• Colon cancer specific survival (CCSC)
• Overall survival (OS)

Planned enrollment: 40 (estimated).

• Emory Decatur Hospital, Atlanta, Georgia
• Emory University Hospital Midtown, Atlanta, Georgia
• Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia
• Emory Saint Joseph's Hospital, Atlanta, Georgia
• Emory Johns Creek Hospital, Johns Creek, Georgia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07140679
• NCI Drug Dictionary: C131334

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 1, 2026. Public record; not medical advice.