ICRN Clinical Trials

Genomic/Immunological Heterogeneity of Intrahepatic Cholangiocarcinoma

A multi-center project to open 3 immuno-oncology clinical trials that will explore genomic and immunological heterogeneity between Asian and US intrahepatic cholangiocarcinoma as a part of the correlative work. This project will be done over 4 years and has been funded by the Department of Defense.

The Principal Investigators are Milind Javle, MD, Medical Oncologist, MD Anderson Cancer Center; Mitesh Borad, MD, Medical Oncologist, Mayo Clinic; and Nilofer Azad, MD, Medical Oncologist, Johns Hopkins.

Atezolizumab With or Without Cobimetinib As A Second Line Therapy for Unresectable and Metastatic Bile Duct Cancer

The ICRN Medical Oncologists worked together and joined this Phase II clinical trial in collaboration with CTEP. Patient enrollment is completed. They received additional funding through UM1 and R01 to support collaborative work on this trial.

The Principal Investigator is Nilofer Azad, MD, Medical Oncologist at Johns Hopkins.

Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable High-Risk IHCCA Patients (NCT03579771)

The ICRN Surgeon and Medical Oncologist initiated the first clinical trial to evaluate the impact of neoadjuvant gemcitabine, cisplatin, and nab-paclitaxel (GAP) for high-risk surgically resected intrahepatic CCA. The aim is to enroll 34 patients from all participating institutions and to assess the efficacy and safety of this neoadjuvant therapy in terms of the radiological response rate, negative margin resection rate, recurrence-free survival rate, overall survival rate, and treatment related adverse events. The trial has been opened at 3 out of the 6 planned sites including Emory University, MD Anderson Cancer Center, and Virginia Mason University.

The Principal Investigator is Shishir Maithel, MD, Surgical Oncologist at Emory University.