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.

Patient Parameters

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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