Study on Radiotherapy Combined with TTI-101 for Patients with Borderline Resectable Pancreatic Cancer
Sponsor: University of Colorado, Denver
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT06141031
This clinical trial is testing the safety and effectiveness of a new treatment combining TTI-101 with targeted radiation therapy for patients with pancreatic cancer that is difficult to remove surgically.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if combining a new drug, TTI-101, with a type of targeted radiation therapy called Stereotactic Body Radiation Therapy (SBRT) is safe and effective for treating pancreatic cancer that is challenging to remove with surgery.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of pancreatic cancer that is difficult to remove surgically, as defined by specific medical guidelines.
- Have received initial chemotherapy as part of standard treatment.
- Be 18 years or older.
- Be willing to sign a consent form and follow all study procedures.
- Be able to swallow tablets.
- Be in relatively good health, with a performance status score indicating ability to carry out daily activities.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1,500/mcL.
- Platelet count of at least 75,000/mcL.
- Hemoglobin level of at least 9 g/dL.
- Serum albumin level of at least 2.8 g/dL.
- Total bilirubin level of 2 mg/dL or lower.
- Liver enzymes within specified limits.
- Kidney function within specified limits.
- Agree to use effective contraception during the study and for 30 days after the last dose if sexually active.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Previous treatment with a STAT inhibitor for the current cancer.
- Use of herbal supplements like St. John's wort or ginseng during the study.
- Not fully recovered from COVID-19 symptoms if previously infected.
- Ongoing side effects from previous treatments, unless mild.
- Recent major surgery or not fully recovered from surgery.
- Severe heart problems or recent heart attack.
- Fluid buildup around the lungs, heart, or abdomen requiring frequent drainage.
- Recent stroke or brain issues.
- Uncontrolled high calcium levels in the blood.
- Bleeding disorders or significant blood clotting issues.
- Severe allergic reactions to similar drugs as TTI-101.
- Active cancer spread to the brain unless stable.
- Digestive issues affecting medication absorption.
- Known HIV infection.
- Chronic hepatitis B unless under control.
- Recent history of other cancers, except for certain skin or cervical cancers.
- Severe uncontrolled medical conditions that pose safety risks.
- Recent treatment for pancreatic cancer outside of initial chemotherapy.
- Distant cancer spread after chemotherapy.
- Participation in other clinical trials or use of investigational drugs recently.
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