Study on Adaptive Dosing of Immunotherapy for Liver Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT07689175
This clinical trial is exploring whether a combination of immunotherapy drugs, nivolumab and ipilimumab, is safe and effective for treating liver cancer. The study focuses on adjusting the dosing based on how well the cancer responds to treatment.
Patient Parameters
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Program Overview
The aim of this study is to test a flexible dosing approach for patients with liver cancer (HCC) and a specific liver condition (Child-Pugh B). The treatment involves using immunotherapy drugs nivolumab and ipilimumab. If the cancer shows a good response on early scans, the treatment plan may be adjusted by the doctor. If the cancer continues to respond well, treatment might be paused or stopped if the risks outweigh the benefits. If the cancer worsens, the doctor will decide on the next steps based on standard care and the patient's health. For those who don't respond well initially, treatment will continue until a positive response is seen or the cancer progresses.
Description
This clinical trial is testing a new way to give immunotherapy drugs, nivolumab and ipilimumab, to patients with liver cancer (HCC) who also have a specific liver condition (Child-Pugh B). The study will pause treatment for a short time to check if the cancer is responding well. If the cancer is under control, the doctor will decide whether to continue, pause, or stop treatment based on the potential benefits and risks. If the cancer gets worse, the doctor will choose the next treatment steps according to standard medical practices and the patient's condition. Patients who don't show a good response at first will keep receiving treatment until they do or until the cancer progresses.
Eligibility Criteria
Inclusion Criteria
- Must have liver cancer confirmed by tests or criteria for patients with cirrhosis. Certain types of liver cancer are not included.
- Must not have had previous treatments with specific immunotherapy drugs for advanced liver cancer.
- Cancer must be advanced or spread and not treatable with surgery or other local treatments, or must have worsened after such treatments.
- Must have a Child-Pugh Score of B7-8.
- Must have measurable cancer that can be tracked by scans.
- Previous local treatments are allowed if the cancer has grown by at least 25% since stopping treatment or if the target cancer area was not treated.
- Must be 18 years or older.
- Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Must have adequate organ and bone marrow function, including specific blood counts and liver and kidney function.
- Must agree to use effective birth control during the study and for 120 days after treatment.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Previous organ transplant.
- Allergic to IV contrast and cannot take pre-medication.
- Cannot be receiving other experimental treatments for the cancer.
- Active autoimmune disease needing treatment, except for certain conditions like asthma.
- HIV infection not controlled with medication.
- Recent cancer treatment for other cancers, except for certain skin or localized cancers.
- Active brain metastases needing immediate treatment.
- Severe allergic reactions to similar treatments.
- Uncontrolled illnesses or conditions that could interfere with the study.
- Cannot be pregnant or nursing.
- Prisoners or those involuntarily incarcerated.
- Significant mental conditions affecting consent ability.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas Southwestern Medical Center | 75390 | Dallas | Texas |
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