[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07140679":3,"trial-entities:NCT07140679":219,"trial-summary:NCT07140679":224},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":81,"secondary_outcomes":86,"sex":107,"minimum_age":108,"maximum_age":109,"healthy_volunteers":15,"eligibility_criteria":110,"std_ages":147,"locations":150,"central_contacts":209,"overall_officials":215,"references":217,"see_also_links":218},"NCT07140679","STUDY00008833","Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer","A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency","RECRUITING","2029-12-31","2025-09","2025-09-25","2025-09-19","Emory University","OTHER",false,"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.","PRIMARY OBJECTIVE:\n\nI. Evaluate the efficacy of adjuvant toripalimab in patients with resected stage IIB, IIC, and III mismatch repair deficient (dMMR) colon cancer by measuring 3-year disease-free survival.\n\nSECONDARY OBJECTIVES:\n\nI. Define the immune related toxicity profile of toripalimab in the adjuvant setting.\n\nII. Further evaluate the efficacy of adjuvant toripalimab specifically by measuring 3-year relapse free survival (RFS), 5-year disease free survival (DFS), and 5-year overall survival.\n\nTERTIARY\u002FEXPLORATORY OBJECTIVES:\n\nI. To explore immune, ctDNA, and omic markers associated with clinical efficacy (DFS).\n\nII. To assess patient reported outcomes (PRO) and health related quality of life (QoL).\n\nOUTLINE:\n\nEligible consenting participants will receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months until 5 years post-resection. After completion of study medication, participants undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life will also be assessed with questionnaires.",[19,20,21,22],"Localized Colon Carcinoma","Stage IIB Colon Cancer AJCC v8","Stage IIC Colon Cancer AJCC v8","Stage III Colon Cancer AJCC v8",[24,25,26,27,28,29,30],"immunotherapy","deficient mismatch repair","colon adenocarcinoma","colon cancer","adjuvant therapy","MSI-H colon adenocarcinoma","dMMR colon cancer","INTERVENTIONAL","TREATMENT",[34],"PHASE2",{"count":36,"type":37},40,"ESTIMATED",[39,48,54,58,67,71],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[44],"Treatment (toripalimab)",[46,47],"Biopsy","BIOPSY_TYPE",{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Biospecimen Collection","Undergo collection of blood samples",[44],[53],"Specimen Collection",{"type":40,"name":55,"description":56,"armGroupLabels":57},"Colonoscopy","Undergo colonoscopy",[44],{"type":40,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Computed Tomography","Undergo CT",[44],[63,64,65,66],"Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan",{"type":14,"name":68,"description":69,"armGroupLabels":70},"Questionnaire Administration","Ancillary studies",[44],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","Toripalimab","Given IV",[44],[77,78,79,80],"Anti-PD-1 Monoclonal Antibody JS001","JS-001","Loqtorzi","Toripalimab-tpzi",[82],{"measure":83,"description":84,"timeFrame":85},"3-year Disease free survival (DFS)","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","Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years",[87,91,95,99,103],{"measure":88,"description":89,"timeFrame":90},"Incidence of treatment-related adverse events","Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Treatment-related adverse events (defined as potentially, probably and definitely) will be summarized in preferred term by system organ class and listed on an individual subject basis at patient level. Immune-related adverse events will also be tabulated.","Up to 5 years",{"measure":92,"description":93,"timeFrame":94},"3-year Relapse free survival (RFS)","Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years","Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.",{"measure":96,"description":97,"timeFrame":98},"5-year DFS","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 5 years.","Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years",{"measure":100,"description":101,"timeFrame":102},"Colon cancer specific survival (CCSC)","CCSC is the time between the date of registration and the date of death due to colon cancer, assessed up to 5 years","Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years",{"measure":104,"description":105,"timeFrame":106},"Overall survival (OS)","Time between the date of registration and the date of death due to any cause.","Time between the date of registration and the date of death due to any cause, assessed up to 5 years","ALL","18 Years",null,{"inclusion":111,"exclusion":133,"raw_text":146},[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132],"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 \u002FmcL","Platelets ≥ 100,000 \u002F mcL","Hemoglobin ≥ 9 g\u002FdL or ≥ 5.0 mmol\u002FL","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\u002Fmin 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 \\\u003C 3.0 mg\u002FdL","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 \u002F 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",[134,135,136,137,138,139,140,141,142,143,144,145],"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\u002Fatopy 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","Inclusion Criteria:\n\n* Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \\[AJCC\\] 8)\n* Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)\n* Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug\n* Available tissue sample from surgical specimen\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Absolute neutrophil count (ANC) ≥ 1,500 \u002FmcL\n* Platelets ≥ 100,000 \u002F mcL\n* Hemoglobin ≥ 9 g\u002FdL or ≥ 5.0 mmol\u002FL\n\n  * Transfusion is allowed to obtain an adequate hemoglobin level\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 40 mL\u002Fmin 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\\])\n\n  * Creatinine clearance should be calculated per institutional standard\n* Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN\n\n  * Patients with previously diagnosed Gilbert syndrome can have total bilirubin \\\u003C 3.0 mg\u002FdL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 x ULN\n* Alkaline phosphatase ≤ 2.5 x ULN\n* Signed informed consent\n* Patients at least 18 years of age\n* 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\n* 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\n* Patients of childbearing \u002F 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\n* 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\n\nExclusion Criteria:\n\n* Neoadjuvant treatment for dMMR colon cancer\n* Presence of metastatic dMMR colon cancer\n* 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\n* Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule\n* History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease\n* History of a hematologic or primary solid tumor malignancy within the last 5 years\n* 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\u002Fatopy not requiring systemic treatment can be enrolled\n* Active hepatitis B or hepatitis C\n* Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n* 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\n* Prior treatment with any immune checkpoint inhibitor\n* Current pregnancy or breastfeeding",[148,149],"ADULT","OLDER_ADULT",[151,169,179,188,197],{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":156,"contacts":157,"geoPoint":166},"Emory Decatur Hospital","Atlanta","Georgia","30033","United States",[158,163],{"name":159,"role":160,"phone":161,"email":162},"Ariana Satcher","CONTACT","404-778-1900","ariana.satcher@emoryhealthcare.org",{"name":164,"role":165},"Oluwadunni Emiloju","PRINCIPAL_INVESTIGATOR",{"lat":167,"lon":168},33.749,-84.38798,{"facility":170,"status":8,"city":153,"state":154,"zip":171,"country":156,"contacts":172,"geoPoint":178},"Emory University Hospital Midtown","30308",[173,176],{"name":174,"role":160,"email":175},"Jalpa Patel","jalpa.r.patel@emory.edu",{"name":177,"role":165},"Oluwadunni E. Emiloju, MBBS, MS",{"lat":167,"lon":168},{"facility":180,"status":8,"city":153,"state":154,"zip":181,"country":156,"contacts":182,"geoPoint":187},"Emory University Hospital\u002FWinship Cancer Institute","30322",[183,186],{"name":184,"role":160,"phone":161,"email":185},"Tyler Whitfield","tyler.stephen.whitfield@emory.edu",{"name":177,"role":165},{"lat":167,"lon":168},{"facility":189,"status":8,"city":153,"state":154,"zip":190,"country":156,"contacts":191,"geoPoint":196},"Emory Saint Joseph's Hospital","30342",[192,195],{"name":193,"role":160,"email":194},"Ainsley Hymel","ainsley.hymel@emory.edu",{"name":177,"role":165},{"lat":167,"lon":168},{"facility":198,"status":8,"city":199,"state":154,"zip":200,"country":156,"contacts":201,"geoPoint":206},"Emory Johns Creek Hospital","Johns Creek","30097",[202,205],{"name":203,"role":160,"email":204},"Hafsa Ahmed","hafsa.maheen.ahmed@emory.edu",{"name":177,"role":165},{"lat":207,"lon":208},34.02893,-84.19858,[210,212],{"name":177,"role":160,"phone":161,"email":211},"oluwadunni.eunice.emiloju@emory.edu",{"name":213,"role":160,"email":214},"Olatunji B. Alese, MD, FASCO","olatunji.alese@emory.edu",[216],{"name":177,"affiliation":180,"role":165},[],[],{"nct_id":4,"conditions":220,"biomarkers":222},[221],"Colon Carcinoma",[223],"MSI1 Gene",{"nct_id":4,"found":225,"summary":226,"prompt_version":236},true,{"design":227,"status":228,"heading":229,"summary":230,"follow_up":231,"word_count":232,"commitments":233,"compensation":234,"drugs_mentioned":235},"This is an interventional study, not specifying a phase, and plans to enroll 40 participants. It is testing the efficacy of adjuvant toripalimab.","completed","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.","Participants are followed up every 6 months until 5 years post-resection after completing study treatment.",111,"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.","Not stated in the trial record.",[],"v2"]