Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
16 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Binyi Xiao, M.D
- Telefonnummer: +86-15800004780
- E-post: xiaoby@sysucc.org.cn
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekrytering
- Sun Yat-sen University Cancer Center
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Kontakt:
- Binyi Xiao, M.D.
- Telefonnummer: +86-1580004780
- E-post: xiaoby@sysucc.org.cn
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Aktiv 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Progression-Free Survival (PFS)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall Survival (OS)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Peirong Ding, M.D., Sun Yat-sen University Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 juni 2026
Primärt slutförande (Beräknad)
30 december 2029
Avslutad studie (Beräknad)
30 december 2034
Studieregistreringsdatum
Först inskickad
16 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- G2025-013
Plan för individuella deltagardata (IPD)
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NEJ
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