ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
24 de septiembre de 2026 actualizado por: Junjie Peng, Fudan University
A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR/MSI-H Colon Cancer
This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR/MSI-H colon cancer. Participants with ctDNA clearance proceed to curative surgery, whereas those with persistent ctDNA positivity escalate to combined PD-1 and CTLA-4 inhibitor therapy.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
This prospective, multicenter, single-arm phase II study evaluates the clinical utility of longitudinal circulating tumor DNA (ctDNA) monitoring to guide neoadjuvant immunotherapy and surgical decision-making in patients with dMMR/MSI-H colon cancer.
Eligible participants will initially receive neoadjuvant PD-1 inhibitor monotherapy. Peripheral-blood ctDNA will be assessed at baseline and after 3 to 4 treatment cycles. Participants with ctDNA clearance will proceed to curative surgery. Participants with persistent ctDNA positivity will be considered to have potential resistance to PD-1 inhibitor monotherapy and will escalate to combined PD-1 and CTLA-4 inhibitor therapy. ctDNA will be reassessed every 2 cycles during combination therapy. Participants will undergo curative surgery after ctDNA clearance or after no more than 4 cycles of combination treatment, regardless of final ctDNA status.
All participants will undergo postoperative ctDNA/minimal residual disease (MRD) testing 1 month after surgery. The study will evaluate pathological response, survival outcomes, the concordance of ctDNA with pathological and imaging assessments, and treatment- and surgery-related safety.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
23
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Junjie Peng, MD, PhD
- Número de teléfono: 86-18017317122
- Correo electrónico: pengjj@shca.org.cn
Copia de seguridad de contactos de estudio
- Nombre: Yaqi Li, MD, PhD
- Correo electrónico: yaqili702@shca.org.cn
Ubicaciones de estudio
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Shanghai, Porcelana, 200000
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Contacto:
- Yaqi Li, MD, PhD
- Número de teléfono: 86-15902194450
- Correo electrónico: yaqili702@shca.org.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Written informed consent obtained before any study-related procedures.
- Age 18 to 75 years, inclusive.
- Histologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma, with the tumor located at least 15 cm from the anal verge.
- dMMR/MSI-H status confirmed by immunohistochemistry, polymerase chain reaction, or next-generation sequencing.
- Eastern Cooperative Oncology Group performance status of 0 or 1 and an expected survival of at least 3 months.
- Adequate hematologic, hepatic, renal, coagulation, thyroid, and cardiac function, as defined in the protocol.
- Negative pregnancy test for women of childbearing potential; agreement to use highly effective contraception, when applicable.
Exclusion Criteria:
- Prior treatment with a PD-1 inhibitor, CTLA-4 inhibitor, or other immunotherapy.
- Symptomatic or high-risk bowel obstruction, bleeding, perforation, pneumonitis, or other conditions that may compromise safe study participation.
- Another malignancy diagnosed within 5 years before the first study treatment, except for specified definitively treated low-risk malignancies.
- Current participation in another interventional clinical study, or receipt of another investigational drug or investigational device within 4 weeks before the first study treatment.
- Active autoimmune disease requiring systemic treatment within 2 years before the first study treatment, or recent systemic corticosteroid or other immunosuppressive therapy.
- Uncontrolled pleural effusion or ascites, prior allogeneic organ transplantation (except corneal transplantation), or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to any study drug component.
- Toxicities or complications from prior treatment not recovered to Grade 1 or baseline, except for specified conditions.
- HIV infection, untreated active hepatitis B infection, or active hepatitis C infection.
- Receipt of a live vaccine within 30 days before the first study treatment.
- Pregnancy or breastfeeding.
- Any serious or uncontrolled systemic disease, active infection, clinically significant laboratory abnormality, or other condition that may interfere with study participation or place the participant at unacceptable risk, as judged by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ctDNA-Guided Neoadjuvant Immunotherapy |
Participants receive PD-1 inhibitor monotherapy. ctDNA testing after 3-4 cycles determines whether they proceed to curative surgery or escalate to PD-1 plus CTLA-4 inhibitor therapy; all participants subsequently undergo curative surgery. |
200 mg intravenously on Day 1 of each 3-week cycle. All participants receive initial monotherapy. 1 mg/kg intravenously on Day 1 of each 3-week cycle. Administered with the PD-1 inhibitor only to participants with persistent ctDNA positivity after 3-4 cycles of monotherapy. Peripheral-blood ctDNA testing at baseline and after 3-4 cycles of monotherapy; every 2 cycles during combination therapy, when applicable; and 1 month after surgery. Curative surgery after ctDNA clearance or after no more than 4 cycles of combination treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pathological Complete Response Rate
Periodo de tiempo: At curative surgery, following completion of neoadjuvant therapy
|
Pathological assessment of the surgical resection specimen; pCR is defined as no residual viable cancer cells after treatment (ypT0N0M0). |
At curative surgery, following completion of neoadjuvant therapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Major Pathological Response Rate
Periodo de tiempo: At curative surgery, following completion of neoadjuvant therapy
|
Pathological assessment of the surgical resection specimen; MPR is defined as residual viable tumor cells ≤10%. |
At curative surgery, following completion of neoadjuvant therapy
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3-Year Event-Free Survival
Periodo de tiempo: From enrollment up to 3 years
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Time from enrollment to first radiographic disease progression or death, whichever occurs first. |
From enrollment up to 3 years
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3-Year Overall Survival
Periodo de tiempo: From enrollment up to 3 years
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Time from enrollment to death from any cause. |
From enrollment up to 3 years
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Concordance of ctDNA Status With Pathological Complete Response
Periodo de tiempo: After 3-4 cycles of PD-1 inhibitor monotherapy (21-day cycles) and at curative surgery; for persistent ctDNA positivity, every 2 cycles of PD-1 plus CTLA-4 inhibitor therapy (21-day cycles; up to 4 cycles).
|
Preoperative ctDNA status will be compared with postoperative pathological complete response results. |
After 3-4 cycles of PD-1 inhibitor monotherapy (21-day cycles) and at curative surgery; for persistent ctDNA positivity, every 2 cycles of PD-1 plus CTLA-4 inhibitor therapy (21-day cycles; up to 4 cycles).
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Concordance Between ctDNA Dynamics and Imaging Assessment
Periodo de tiempo: Baseline through curative surgery, up to 24 weeks (each cycle is 21 days).
|
ctDNA positivity, clearance, and dynamic changes will be compared with RECIST version 1.1 imaging response assessments. |
Baseline through curative surgery, up to 24 weeks (each cycle is 21 days).
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Number of Participants With Treatment-Emergent Adverse Events, as Assessed by CTCAE v5.0
Periodo de tiempo: From first dose through 30 days after the last dose.
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Number and proportion of participants with at least one treatment-emergent adverse event, including treatment-related and immune-related adverse events. |
From first dose through 30 days after the last dose.
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Number of Participants With Grade 3 or Higher Treatment-Related Adverse Events, as Assessed by CTCAE v5.0
Periodo de tiempo: From first dose through 30 days after the last dose.
|
Number and proportion of participants with at least one Grade 3 or higher treatment-related adverse event. |
From first dose through 30 days after the last dose.
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Number of Participants With Serious Adverse Events
Periodo de tiempo: From first dose through 90 days after the last dose.
|
Number and proportion of participants with at least one serious adverse event. |
From first dose through 90 days after the last dose.
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Number of Participants With Treatment-Related Delay of Curative Surgery
Periodo de tiempo: From first dose through curative surgery up to 24 weeks
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Number and proportion of participants whose curative surgery is delayed because of treatment-related toxicity, as determined by the investigator. |
From first dose through curative surgery up to 24 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
- Koopman M, Kortman GA, Mekenkamp L, Ligtenberg MJ, Hoogerbrugge N, Antonini NF, Punt CJ, van Krieken JH. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 2009 Jan 27;100(2):266-73. doi: 10.1038/sj.bjc.6604867.
- Overman MJ, Lonardi S, Wong KYM, Lenz HJ, Gelsomino F, Aglietta M, Morse MA, Van Cutsem E, McDermott R, Hill A, Sawyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine JM, Cao ZA, Kamble S, Kopetz S, Andre T. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
- Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fourchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zhong WY, Fogelman D, Marinello P, Andre T; KEYNOTE-177 Investigators. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022 May;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8. Epub 2022 Apr 12.
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- Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, Andre T. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
14 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de septiembre de 2026
Publicado por primera vez (Actual)
25 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades del Colon
- Procesos Neoplásicos
- Condiciones Patológicas, Signos y Síntomas
- Neoplasia Residual
- Neoplasias colónicas
- Agentes antineoplásicos inmunológicos
- Agentes antineoplásicos
- Mecanismos moleculares de acción farmacológica.
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Inhibidores de puntos de control inmunitarios
Otros números de identificación del estudio
- Neo-ctDNA-Colon
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data, including de-identified data, will not be made available to external researchers. Study data will be processed and stored within China. Aggregate results may be published without identifiable participant information.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .