Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
16. August 2026 aktualisiert von: Pei-Rong Ding, Sun Yat-sen University
This study aims to evaluate whether plasma molecular residual disease (MRD), assessed using circulating tumor DNA (ctDNA), can help optimize the duration of immunotherapy in patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.
Patients with MSI-H/dMMR metastatic colorectal cancer can achieve durable responses to immune checkpoint inhibitors, but the optimal duration of treatment remains uncertain. Prolonged immunotherapy may increase treatment burden and the risk of immune-related adverse events. ctDNA-based MRD testing may provide a sensitive method for detecting residual tumor burden and identifying patients who may be able to safely stop treatment.
In this study, patients receiving immunotherapy will undergo serial plasma MRD testing. After completing 1 year of immunotherapy, patients with two consecutive negative MRD results will be randomly assigned to either continue immunotherapy or stop treatment and enter observation. Patients will then be followed every 3 months for 2 years with MRD testing and routine clinical assessments, including imaging and laboratory examinations.
The study will compare clinical outcomes between the two groups and evaluate whether serial plasma MRD monitoring can support a more individualized approach to the duration of immunotherapy in MSI-H/dMMR metastatic colorectal cancer.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
100
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Binyi Xiao, M.D
- Telefonnummer: +86-15800004780
- E-Mail: xiaoby@sysucc.org.cn
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Rekrutierung
- Sun Yat-sen University Cancer Center
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Kontakt:
- Binyi Xiao, M.D.
- Telefonnummer: +86-1580004780
- E-Mail: xiaoby@sysucc.org.cn
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Voluntary participation in the study and provision of written informed consent.
- Age ≥18 years at the time of signing informed consent.
- Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.
- Clinically confirmed stage IV disease.
- No prior immunotherapy for the current colorectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)/MRD analysis.
- Life expectancy >12 months.
- Willing and able to comply with the study procedures and scheduled follow-up.
Exclusion Criteria:
- Presence of another malignancy.
- Prior immunotherapy for the current stage IV colorectal cancer.
- Organ transplantation within 3 months before enrollment.
- History of blood transfusion within 3 months before enrollment.
- Active, known, or suspected autoimmune disease, or evidence of active or chronic infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
- Pregnancy or breastfeeding.
- Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.
- Failure to provide written informed consent.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: MRD-Guided Treatment Discontinuation
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to discontinue immunotherapy.
Patients will enter observation and undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to discontinue immunotherapy.
Patients will enter observation and undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Aktiver Komparator: Continued Immunotherapy
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to continue immunotherapy for a total treatment duration of 2 years.
Patients will undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to continue immunotherapy for a total treatment duration of 2 years.
Patients will undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Sonstiges: Observational Cohort
Patients who achieve disease control for at least 6 months after immunotherapy will undergo plasma MRD testing and prospective follow-up.
The study will not interfere with subsequent treatment decisions, including discontinuation or continuation of immunotherapy, surgery, or local treatment.
Patients will undergo routine clinical follow-up and serial MRD monitoring according to the study schedule.
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Patients who achieve disease control for at least 6 months after immunotherapy will undergo plasma MRD testing and prospective follow-up.
The study will not interfere with subsequent treatment decisions, including discontinuation or continuation of immunotherapy, surgery, or local treatment.
Patients will undergo routine clinical follow-up and serial MRD monitoring according to the study schedule.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Progression-Free Survival (PFS)
Zeitfenster: From randomization to disease progression, death, or up to 2 years
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Progression-free survival is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Participants without disease progression or death will be censored at the date of the last disease assessment.
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From randomization to disease progression, death, or up to 2 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Overall Survival (OS)
Zeitfenster: From randomization to death from any cause or up to 3 years
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Overall survival is defined as the time from randomization to death from any cause.
Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.
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From randomization to death from any cause or up to 3 years
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Incidence of Immune-Related Adverse Events (irAEs)
Zeitfenster: From randomization through 2 years of follow-up
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The incidence of immune-related adverse events will be assessed during the study.
The proportion of participants experiencing immune-related adverse events will be recorded and compared between the treatment-discontinuation and continued-immunotherapy groups.
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From randomization through 2 years of follow-up
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Peirong Ding, M.D., Sun Yat-sen University Cancer Center
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. Juni 2026
Primärer Abschluss (Geschätzt)
30. Dezember 2029
Studienabschluss (Geschätzt)
30. Dezember 2034
Studienanmeldedaten
Zuerst eingereicht
16. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. August 2026
Zuerst gepostet (Tatsächlich)
20. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- G2025-013
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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