ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
24 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
23
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Junjie Peng, MD, PhD
- Telefonnummer: 86-18017317122
- E-post: pengjj@shca.org.cn
Studera Kontakt Backup
- Namn: Yaqi Li, MD, PhD
- E-post: yaqili702@shca.org.cn
Studieorter
-
-
-
Shanghai, Kina, 200000
- Rekrytering
- Fudan University Shanghai Cancer Center
-
Kontakt:
- Yaqi Li, MD, PhD
- Telefonnummer: 86-15902194450
- E-post: yaqili702@shca.org.cn
-
-
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
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pathological Complete Response Rate
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Major Pathological Response Rate
Tidsram: 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
|
|
3-Year Event-Free Survival
Tidsram: From enrollment up to 3 years
|
Time from enrollment to first radiographic disease progression or death, whichever occurs first. |
From enrollment up to 3 years
|
|
3-Year Overall Survival
Tidsram: From enrollment up to 3 years
|
Time from enrollment to death from any cause. |
From enrollment up to 3 years
|
|
Concordance of ctDNA Status With Pathological Complete Response
Tidsram: 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).
|
|
Concordance Between ctDNA Dynamics and Imaging Assessment
Tidsram: 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).
|
|
Number of Participants With Treatment-Emergent Adverse Events, as Assessed by CTCAE v5.0
Tidsram: From first dose through 30 days after the last dose.
|
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.
|
|
Number of Participants With Grade 3 or Higher Treatment-Related Adverse Events, as Assessed by CTCAE v5.0
Tidsram: 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.
|
|
Number of Participants With Serious Adverse Events
Tidsram: 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.
|
|
Number of Participants With Treatment-Related Delay of Curative Surgery
Tidsram: From first dose through curative surgery up to 24 weeks
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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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 (Beräknad)
14 september 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2030
Studieregistreringsdatum
Först inskickad
12 september 2026
Först inskickad som uppfyllde QC-kriterierna
24 september 2026
Första postat (Faktisk)
25 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 september 2026
Senast verifierad
1 september 2026
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Tarmsjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Kolorektala neoplasmer
- Intestinala neoplasmer
- Kolonsjukdomar
- Neoplastiska processer
- Patologiska tillstånd, tecken och symtom
- Neoplasma, rest
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- Antineoplastiska medel, immunologiska
- Antineoplastiska medel
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- Farmakologiska åtgärder
- Kemiska åtgärder och användningar
- Terapeutisk användning
- Immune Checkpoint-hämmare
Andra studie-ID-nummer
- Neo-ctDNA-Colon
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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Nej
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