Study on Tremelimumab and Durvalumab with Chemotherapy for Treating Intrahepatic Cholangiocarcinoma

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06017297

Provider View

This clinical trial is testing a combination of two immunotherapy drugs, tremelimumab and durvalumab, with chemotherapy drugs gemcitabine and cisplatin, to see if they can make surgery possible for patients with a specific type of liver cancer that is hard to remove or likely to come back.

Patient Parameters

Program Overview

The aim of this study is to find out if a combination of immunotherapy drugs (tremelimumab and durvalumab) and chemotherapy drugs (gemcitabine and cisplatin) can safely and effectively shrink tumors in patients with intrahepatic cholangiocarcinoma, a type of liver cancer. This treatment is given before surgery to see if it can make the cancer removable. The study will also look at the side effects of this treatment. Participants will have a tumor biopsy, imaging, and lab tests before starting the treatment. They will receive four cycles of the drug combination, and if the tumor becomes removable, they will have surgery. If not, they will receive more cycles and additional treatments if necessary.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older, of any gender or ethnicity.
  • Diagnosed with intrahepatic cholangiocarcinoma that has not been treated with systemic therapy.
  • No cancer spread outside the liver, except for certain lymph nodes.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of more than 6 months.
  • Cancer that is not easily removable by surgery but could be if it shrinks.
  • At least one tumor that can be measured by scans.
  • Adequate blood cell counts and organ function based on specific tests.
  • Must have health insurance in the US.
  • Able to give informed consent and follow study procedures.
  • Weigh at least 30 kg (about 66 pounds).

Exclusion Criteria

  • Have other types of bile duct cancer or liver cancer.
  • Eligible for surgery or liver transplant based on tumor characteristics.
  • Not suitable for surgery due to other health issues.
  • Cancer spread beyond certain lymph nodes.
  • Allergic to any of the study drugs.
  • Unresolved side effects from previous cancer treatments, except for hair loss or skin changes.
  • Recent major surgery or radiation affecting a large area.
  • Active autoimmune or inflammatory disorders, except for certain stable conditions.
  • History of certain heart or lung conditions.
  • Recent live vaccine or active infections like HIV or tuberculosis.
  • Pregnant or breastfeeding women, or those not using effective contraception.
  • Other active cancers within the last 5 years, except for certain early-stage cancers.
  • Unable to sign consent or follow study procedures due to legal or personal reasons.
  • Participation in another clinical trial within the last 4 weeks.

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