Study on Combining Chemotherapy and Immunotherapy with Yittrium-90 for Better Tumor Control
Sponsor: Inova Health Care Services
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT05422690
This clinical trial is testing whether combining chemotherapy drugs gemcitabine, cisplatin, and the immunotherapy drug durvalumab with a direct tumor treatment called Yittrium-90 can more effectively shrink tumors and control cancer.
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Program Overview
The aim of this study is to find out if using a combination of chemotherapy drugs (gemcitabine and cisplatin) and an immunotherapy drug (durvalumab) along with a direct tumor treatment called Yittrium-90 can work better together to shrink tumors and control cancer.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Diagnosed with a specific type of liver cancer (iCCA) that has not been treated before, or if treated, it was more than 6 months ago.
- Cancer that cannot be surgically removed safely.
- Tumors that can be measured and are at least 2 cm in size.
- Good overall health with a performance status score of 0 or 1.
- No liver cirrhosis or signs of it on imaging tests.
- No cancer outside the liver, except for nearby lymph nodes that can be removed during surgery.
- Good organ function based on lab tests.
- Able to complete all required tests and procedures in the study.
- Willing to give consent to participate in the study.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- History of organ transplant.
- Active or past autoimmune diseases or immune deficiencies, with some exceptions like controlled thyroid or diabetes conditions.
- Recent use of immunosuppressive medications, with some exceptions for low-dose or specific types of steroids.
- Certain liver conditions or other types of cancer like gallbladder or pancreatic cancer.
- Blood clots in major liver veins.
- Previous treatments for iCCA, except for specific allowed therapies.
- Allergies to study drugs.
- Active hepatitis B or C without treatment.
- Certain conditions found during angiography that prevent safe treatment.
- Large tumor burden in the liver.
- Inability to protect non-target areas during treatment.
- Low serum albumin or high liver enzyme levels.
- Other serious illnesses or conditions that pose additional risks.
- Poor compliance or inability to follow study procedures.
- Prisoners or those involuntarily incarcerated.
- Cognitive impairments affecting decision-making.
- Participation in another clinical trial.
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