Immunotherapy (Toripalimab) to Lower the Risk of Colon Cancer Coming Back After Surgery
Sponsor: Emory University
ClinicalTrials ID:NCT07140679
This study is testing if the immunotherapy drug toripalimab can help prevent colon cancer from returning after surgery in patients with certain types of colon cancer that have a specific genetic feature called mismatch repair deficiency.
Patient Parameters
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Program Overview
The purpose of this phase II study is to see how well the immunotherapy drug toripalimab works in reducing the chance of colon cancer coming back after surgery in patients with stage IIB, IIC, or III colon cancer that has a mismatch repair deficiency. The study will measure how many patients remain cancer-free for three years after treatment.
Description
The main goal of this study is to see if toripalimab can help patients with certain types of colon cancer stay cancer-free for three years after surgery. Researchers will also look at how safe the drug is and how it affects patients' quality of life.
Participants will receive toripalimab through an IV every three weeks for six months, totaling eight doses, as long as the cancer does not return or there are no severe side effects. After finishing the treatment, patients will have follow-up visits every six months for up to five years. These visits will include blood tests, CT scans, and colonoscopies to monitor their health. Patients will also fill out questionnaires about their quality of life.
Eligibility Criteria
Inclusion Criteria
- Have had surgery to remove stage IIB, IIC, or III colon cancer with mismatch repair deficiency.
- Cancer must be confirmed as mismatch repair deficient by specific lab tests.
- Surgery must have been completed 4 to 12 weeks before starting the study treatment.
- Must provide a tissue sample from the surgery.
- Be in good overall health with an ECOG performance status of 0, 1, or 2.
- Meet specific blood count and organ function requirements.
- Be at least 18 years old.
- Have had a full colonoscopy before joining the study.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during and for 90 days after treatment.
- Men and women of reproductive potential must agree to use effective birth control during and after treatment.
- Women who are breastfeeding must stop before starting treatment and for 90 days after the last dose.
Exclusion Criteria
- Have received treatment before surgery for mismatch repair deficient colon cancer.
- Have colon cancer that has spread to other parts of the body.
- Have medical conditions that could make the study treatment unsafe or affect the study results.
- Have uncontrolled mental health conditions that could affect participation.
- Have a history of lung inflammation or lung disease requiring treatment.
- Have had another type of cancer in the last five years.
- Have an autoimmune disease requiring treatment in the past two years, except for certain conditions like type 1 diabetes or controlled thyroid issues.
- Have active hepatitis B or C.
- Are taking systemic steroids or immunosuppressive therapy within seven days before starting treatment.
- Have received live vaccines within 30 days before starting treatment.
- Have previously been treated with immune checkpoint inhibitors.
- Are currently pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Emory Decatur Hospital | 30033 | Atlanta | Georgia |
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| Emory Saint Joseph's Hospital | 30342 | Atlanta | Georgia |
| Emory Johns Creek Hospital | 30097 | Johns Creek | Georgia |
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