ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
torstai 24. syyskuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
23
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Junjie Peng, MD, PhD
- Puhelinnumero: 86-18017317122
- Sähköposti: pengjj@shca.org.cn
Tutki yhteystietojen varmuuskopiointi
- Nimi: Yaqi Li, MD, PhD
- Sähköposti: yaqili702@shca.org.cn
Opiskelupaikat
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Shanghai, Kiina, 200000
- Rekrytointi
- Fudan University Shanghai Cancer Center
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Ottaa yhteyttä:
- Yaqi Li, MD, PhD
- Puhelinnumero: 86-15902194450
- Sähköposti: yaqili702@shca.org.cn
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pathological Complete Response Rate
Aikaikkuna: At curative surgery, following completion of neoadjuvant therapy
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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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Major Pathological Response Rate
Aikaikkuna: At curative surgery, following completion of neoadjuvant therapy
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline through curative surgery, up to 24 weeks (each cycle is 21 days).
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: From first dose through 90 days after the last dose.
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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
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Opintojen ennätyspäivät
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Neoplasmat sivustoittain
- Neoplasmat
- Suoliston sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Kolorektaaliset kasvaimet
- Suoliston kasvaimet
- Paksusuolen sairaudet
- Neoplastiset prosessit
- Patologiset tilat, merkit ja oireet
- Neoplasma, jäännös
- Paksusuolen kasvaimet
- Antineoplastiset aineet, immunologiset
- Antineoplastiset aineet
- Farmakologisen vaikutuksen molekyylimekanismit
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Terapeuttinen käyttö
- Immuunijärjestelmän tarkistuspisteen estäjät
Muut tutkimustunnusnumerot
- Neo-ctDNA-Colon
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
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.
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Ei
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Ei
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