Phase II Study of Tremelimumab, Durvalumab, Gemcitabine, and Cisplatin for Advanced Liver and Bile Duct Cancer

Sponsor: Mehmet Akce

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06855225

Provider View

This clinical trial is testing a combination of immunotherapy and chemotherapy drugs to see if they can help control advanced liver and bile duct cancer that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The study is exploring a treatment plan that includes the immunotherapy drugs Tremelimumab and Durvalumab, along with chemotherapy drugs Gemcitabine and Cisplatin, for patients with advanced liver and bile duct cancer. The treatment is given in cycles, with the first eight cycles every three weeks and subsequent cycles every four weeks. Patients will undergo regular health checks and scans to monitor the cancer's response to the treatment. The study will continue until the cancer progresses, side effects become too severe, or the patient or doctor decides to stop.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and agree to follow study requirements.
  • Aged 18 years or older.
  • Weigh more than 30 kg (about 66 pounds).
  • Diagnosed with advanced liver and bile duct cancer that cannot be surgically removed.
  • Have measurable cancer according to specific medical criteria.
  • Expected to live at least 12 more weeks.
  • In good general health, with a performance status of 0 or 1.
  • Have adequate blood cell counts and organ function based on lab tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Willing to provide a tumor sample if available and undergo a biopsy if needed.
  • Agree to return for follow-up visits and comply with study procedures.

Exclusion Criteria

  • Recent heart attack or severe heart problems.
  • Participation in another clinical study with an investigational product recently.
  • Recent liver-directed therapy.
  • Unresolved severe side effects from previous cancer treatments.
  • Currently receiving other cancer treatments not part of the study.
  • Previous treatment with certain study drugs for advanced cancer.
  • Use of immunosuppressive medication recently, with some exceptions.
  • Recent receipt of a live vaccine.
  • Recent major surgery.
  • History of organ transplantation.
  • Active or recent autoimmune or inflammatory disorders.
  • Uncontrolled illnesses or infections.
  • History of another primary cancer, with some exceptions.
  • Brain metastases or spinal cord compression unless stable after treatment.
  • Certain heart conditions or infections, including hepatitis and HIV.
  • Active tuberculosis infection.
  • Pregnant or breastfeeding women, or those not using effective birth control.

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