Study on Durvalumab, Tremelimumab, and Radiation Therapy for Liver and Biliary Tract Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03482102

Provider View

This clinical trial is exploring a new treatment combination using the drugs Durvalumab and Tremelimumab, along with radiation therapy, to treat liver cancer (Hepatocellular Carcinoma) and bile duct cancer (Biliary Tract Cancer).

Patient Parameters

Program Overview

The study is testing whether a combination of two drugs, Durvalumab and Tremelimumab, with radiation therapy can help treat liver and bile duct cancers. These drugs are antibodies that work with the immune system to target cancer cells. The goal is to see if this combination can stop the cancer from growing and spreading.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of the treatment. The drugs being studied, Durvalumab and Tremelimumab, are not yet approved by the FDA for these specific cancers, but they have shown promise in other uses. These drugs are designed to help the immune system fight cancer by targeting proteins that cancer cells use to hide from the immune system. The study will also use radiation therapy to target cancer cells directly. Researchers hope that this combination will be more effective in stopping the cancer from growing and spreading.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (Hepatocellular Carcinoma) or bile duct cancer (Biliary Tract Cancer).
  • Cancer is advanced, cannot be removed by surgery, or has spread to other parts of the body.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one tumor that has not been treated with radiation and is suitable for radiation therapy.
  • Have not received immunotherapy before.
  • Have tried and not responded to, or cannot take, certain standard treatments like sorafenib for liver cancer or gemcitabine-based chemotherapy for bile duct cancer.
  • Known status of Hepatitis B and C infections, with appropriate treatment if positive.
  • Weigh at least 30 kg (about 66 pounds).
  • Have a Child-Pugh Score of A, or B7 without severe liver symptoms.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Women must not be pregnant and must agree to use effective contraception during the study.
  • Willing to sign an informed consent form and comply with study requirements.

Exclusion Criteria

  • Have a specific type of liver cancer called fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and liver cancer.
  • Have had radiation therapy to the area planned for treatment in this study.
  • Have received prior immunotherapy treatments.
  • Are participating in another clinical trial that involves treatment.
  • Have received live vaccines within 30 days before starting the study.
  • Have certain heart conditions or a history of organ transplantation.
  • Have active autoimmune diseases or inflammatory bowel disease.
  • Have had another type of cancer within the last 2 years, except for certain non-threatening cancers.
  • Have allergies to the study drugs or their components.
  • Have lung conditions that required steroids or have active lung disease.
  • Have uncontrolled illnesses or infections, including tuberculosis, hepatitis B or C, or HIV.
  • Are pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have unresolved side effects from previous cancer treatments, except for certain conditions like hair loss or skin changes.
  • Have had major surgery within 28 days before starting the study.
  • Have brain metastases or spinal cord compression unless stable and treated.

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