Phase II Study of Immunochemotherapy Before Surgery for Treatable Colon Cancer: NICER
Sponsor: Baylor College of Medicine
ClinicalTrials ID:NCT05870800
This clinical trial is testing a combination of immunotherapy and chemotherapy given before surgery to see if it can improve treatment outcomes for patients with treatable colon cancer. The study will also look at how safe and feasible this approach is.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring whether a combination of the immunotherapy drug atezolizumab and chemotherapy drugs (CAPOX) given before surgery can improve treatment results for patients with treatable colon cancer. The trial aims to enroll 28 patients and will assess if this approach can be safely administered and lead to better responses by increasing immune cells in the tumor. Patients will receive four cycles of atezolizumab and CAPOX before surgery. After surgery, those at high risk of cancer returning may receive additional chemotherapy. Blood samples will be collected at various stages to monitor changes in tumor DNA as an early sign of treatment effectiveness. The study will end for each patient at their 6-month post-surgery visit.
Description
This trial is testing a new treatment approach for patients with treatable colon cancer. It involves giving a combination of immunotherapy (atezolizumab) and chemotherapy (CAPOX) before surgery to see if it can improve treatment outcomes. The study will include 28 patients and aims to determine if this combination can be safely given and lead to better responses by increasing immune cells in the tumor. Patients will receive four cycles of atezolizumab and CAPOX before surgery. After surgery, those at high risk of cancer returning may receive additional chemotherapy. Blood samples will be collected at various stages to monitor changes in tumor DNA as an early sign of treatment effectiveness. The study will end for each patient at their 6-month post-surgery visit.
Patients will be followed up for six months after surgery to assess the treatment's effectiveness. After this period, they will enter a long-term follow-up phase, with visits every six months until three years after surgery. During these visits, patients will have the option to provide blood and stool samples and complete quality of life questionnaires.
Research procedures include collecting blood and stool samples for future analysis and quality of life assessments through questionnaires. These samples will be stored for up to 10 years for future research. Data collected during the study will be kept confidential and stored securely.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent form
- Age over 18 years
- Ability to follow the study protocol
- Confirmed diagnosis of treatable non-metastatic colon cancer (stages I-III)
- Tumor located at least 12 cm from the anal verge
- Availability of a tumor sample for DNA analysis
- High-risk features such as high CEA levels, low lymphocyte-to-monocyte ratio, poor tumor differentiation, lymphovascular or perineural invasion, or large tumor size
- Good overall health with specific blood test results within normal ranges
- Negative tests for hepatitis B, hepatitis C, and HIV
- Women of childbearing potential must agree to use effective contraception during and after treatment
- Men must agree to use contraception and refrain from donating sperm during and after treatment
Exclusion Criteria
- Active or untreated metastatic disease
- History of certain diseases like leptomeningeal disease or uncontrolled pain
- Uncontrolled high calcium levels
- History of autoimmune diseases or immune deficiencies, with some exceptions
- History of lung diseases like pulmonary fibrosis or pneumonitis
- Active tuberculosis
- Significant heart disease or recent major surgery
- History of other cancers within the last five years, with some exceptions
- Severe infections or recent antibiotic treatment
- Prior organ transplants
- Recent live vaccine administration
- Current antiviral therapy for hepatitis B
- History of multiple primary cancers
- Recent investigational therapy
- Prior treatment with certain immune therapies
- Recent use of immunostimulatory or immunosuppressive medications
- Severe allergic reactions to study drugs
- Pregnancy or breastfeeding, or planning to become pregnant during or after the study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Baylor College of Medicine | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.