Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07140679
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Localized Colon Carcinoma
  • Stage IIB Colon Cancer AJCC v8
  • Stage IIC Colon Cancer AJCC v8
  • Stage III Colon Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Colonoscopy — PROCEDURE
    Undergo colonoscopy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Toripalimab — DRUG
    Given IV

Study Details

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

Key Dates

Start date
Sep 19, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (toripalimab)
    Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence.

Primary Outcome Measure

3-year Disease free survival (DFS) [ Time Frame: Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Emory Decatur HospitalAtlantaGeorgia30033
Ariana Satcher
[email protected]
404-778-1900
Oluwadunni Emiloju (PRINCIPAL_INVESTIGATOR)
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Ainsley Hymel
[email protected]
Oluwadunni E. Emiloju, MBBS, MS (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Oluwadunni E. Emiloju, MBBS, MS (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Tyler Whitfield
[email protected]
404-778-1900
Oluwadunni E. Emiloju, MBBS, MS (PRINCIPAL_INVESTIGATOR)
Emory Johns Creek HospitalJohns CreekGeorgia30097
Oluwadunni E. Emiloju, MBBS, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Decatur Hospital· Atlanta, GAEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAEmory Johns Creek Hospital· Johns Creek, GA

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