Study on Combining Durvalumab and Histotripsy for Treating Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria

• Diagnosed with intrahepatic cholangiocarcinoma confirmed by a biopsy.
• Cancer is under control after 18 weeks of standard chemotherapy and immunotherapy.
• Currently on maintenance durvalumab therapy after initial treatment success.
• Tumor suitable for biopsy and histotripsy treatment.
• Able to undergo a liver biopsy of a specific tumor area.
• Tumor is considered suitable for histotripsy treatment.
• Cancer cannot be removed by surgery or patient is not a candidate for surgery.
• Can undergo general anesthesia.
• Has a Child-Pugh Score of A or B (up to B8).
• Has an ECOG performance status of 0-2, indicating good overall health.
• Meets specific liver, kidney, and blood function criteria within 7 days before treatment.
• INR score less than 3.0 within 7 days before treatment.
• Women of childbearing potential must have a negative pregnancy test within 7 days before joining the study.
• Agree to use effective contraception during the study and for a specified period after the last dose of study drugs.
• Able to understand and comply with study procedures.

Exclusion Criteria

• Pregnant, planning to become pregnant, or breastfeeding during the study.
• Participating in another clinical trial or using investigational treatments within 30 days before the study.
• Have health conditions that pose a risk for histotripsy treatment, such as lung disease.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Had major surgery or significant injury within 2 weeks before the study and not fully recovered.
• Have not recovered from side effects of previous cancer treatments, except for certain conditions.
• Have a history of bleeding disorders or uncorrectable blood clotting issues.
• Histotripsy is not considered a treatment option by the investigator.
• Have conditions that could affect safety or compliance with the study.
• Tumors are not suitable for treatment as determined by a radiologist.
• Allergic to contrast media and cannot be pre-medicated.
• Tumors have had prior local treatments like ablation or radiation.
• History of organ or bone marrow transplant.
• Have another cancer that could interfere with the study.
• Have significant mental health issues affecting consent.
• Have untreated brain metastasis.
• Received a live vaccine within 28 days before starting durvalumab.