A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

Clinical Trial Details

The purpose of this study is to test the good and bad effects of the drug called durvalumab in combination with the chemotherapy drugs gemcitabine and cisplatin. We are doing this study because we want to find out if this approach is better or worse than the usual approach for liver cancer.

The combination of gemcitabine, cisplatin, and durvalumab has been approved by the U.S. Food and Drug Administration (FDA) as front line therapy for advanced biliary tract cancers, including intrahepatic cholangiocarcinoma.

All study participants will receive durvalumab, gemcitabine, and cisplatin for up to 12 weeks. After the first 6 weeks of treatment, participants will undergo restaging with imaging and a doctor’s visit to make sure that it is reasonable to continue with the second half of the preoperative treatment.

After completing the 12 weeks of treatment, participants will be evaluated to make sure they are fit to go to surgery. After recovering from the operation, the doctors will determine whether participants are able to receive the study drugs after surgery for up to 12 more weeks.

Key Eligibility: 
  1. Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation.
  2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
  3. Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in hepatobiliary surgery.
  4. Over the age of 18

Detailed eligibility will be discussed with the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2505028869

ClinicalTrials.gov:

NCT06050252

Sponsor:

10608

Status

Open to Enrollment

Age Group

Adult

Sponsor