Study on Durvalumab with Gemcitabine and Cisplatin for Treating High-Risk Liver Cancer Before Surgery

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06050252

Provider View

This clinical trial is testing whether a combination of the immunotherapy drug durvalumab with chemotherapy drugs gemcitabine and cisplatin, given before surgery, can help shrink tumors in patients with high-risk liver cancer that can be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to see if using durvalumab, an immunotherapy drug, together with chemotherapy drugs gemcitabine and cisplatin before surgery can effectively reduce the size of tumors in patients with high-risk liver cancer (cholangiocarcinoma) that can be removed by surgery. Durvalumab may help stop cancer cells from growing and spreading, while gemcitabine and cisplatin work to kill cancer cells or stop them from dividing. This combination might make the tumor smaller and reduce the amount of normal tissue that needs to be removed during surgery.

Description

The main goal of this study is to see how many patients can complete the treatment with durvalumab, gemcitabine, and cisplatin before having surgery to remove their liver cancer. Researchers also want to find out how well the treatment works in shrinking the cancer and improving survival rates.

Patients will receive durvalumab through an IV on day 1, along with gemcitabine and cisplatin on days 1 and 8, for 4 cycles. After these treatments, patients will have surgery to remove the cancer. If needed, patients may continue receiving the same treatment for up to 4 more cycles after surgery. Each cycle lasts 21 days, as long as the cancer does not progress or cause unacceptable side effects.

Throughout the study, patients will have CT or MRI scans and blood tests, and tissue samples will be collected to monitor the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, every 6 months for 5 years, and then yearly.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of intrahepatic cholangiocarcinoma (iCCA) that can be surgically removed.
  • Must have at least one measurable tumor that can be accurately measured by scans or clinical exams.
  • Must be a suitable candidate for surgery, as determined by a qualified surgeon.
  • High-risk iCCA is defined by factors such as:
    • Tumor size greater than 5 cm.
    • Multiple tumors in the same liver lobe.
    • Invasion into blood vessels.
    • Suspected or confirmed spread to nearby lymph nodes.
    • CA 19-9 level greater than 200 U/mL.
  • Must not have received prior treatment for iCCA.
  • Must be 18 years or older and weigh more than 30 kg.
  • Must have a good performance status and adequate blood counts and organ function.
  • Women must not be pregnant and must use effective contraception if of childbearing potential.
  • Must have a life expectancy of at least 12 weeks.
  • HIV-positive patients must have an undetectable viral load.
  • Patients with hepatitis B or C must have controlled or treated infections.
  • Patients with treated brain metastases are eligible if stable.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Must have recovered from any significant side effects of previous treatments.
  • Must not have had major surgery within 14 days before starting the study treatment.
  • Must not be using immunosuppressive medications, with some exceptions for low-dose steroids.
  • Must not have received a live vaccine within 30 days before starting the study treatment.
  • Must not be participating in another clinical trial or taking investigational drugs.
  • Must not have allergies to similar drugs used in the study.
  • Must not have uncontrolled illnesses or conditions that make the study unsafe.
  • Pregnant or breastfeeding women are excluded due to potential risks to the baby.
  • Must not have active autoimmune or inflammatory disorders, with some exceptions for stable conditions.
  • Must not have active infections like tuberculosis or uncontrolled hepatitis B or C.
  • Must not have a history of organ transplantation.

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