Summary of ICRN Projects

For more information about any of these ongoing projects, please contact Dr. Reham Abdel-Wahab, MD, PhD, Director of Research and Chief Scientific Officer at the Cholangiocarcinoma Foundation at reham.abdelwahab@cholangiocarcinoma.org.

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.

Intrahepatic Cholangiocarcinoma Radiation Therapy Outcome

The Radiation Oncologist members are working together to build the first multi-institution retrospective database to explore the outcome of various radiation therapy approaches in the management of CCA patients.

The Principal Investigator is Eugene Koay, MD, Radiation Oncologist at MD Anderson Cancer Center.

Development of FGFR Mutated CCA Organoids

This pilot study is in partnership with SEngine to develop a 15 viable FGFR mutated CCA from biopsy or surgically resected fresh tissue samples.

The Principal Investigator is Milind Javle MD, Medical Oncologist at MD Anderson Cancer Center and Former Chair of the ICRN.

Natural History of Various Biliary Tract Cancer Molecular Subtypes

Given the rarity of biliary tract cancers, ICRN members are working together to build a centralized database for all biliary tract cancers from US and non-US cancer institutions. This database will be globally invaluable in:

  • Characterizing the clinical history of various CCA molecular subtypes
  • Assessing the frequency of various CCA molecular subtypes by geography
  • Creating a database of outcomes from standard therapies for patients with CCA with specific molecular alterations
  • Serving as a reference for clinical investigators, scientists, pharmaceutical companies, and policy makers in their efforts to understand disease biology, design clinical trials, and approve drugs for patients

The Principal Investigators are Milind Javle, MD, Medical Oncologist, MD Anderson Cancer Center; and Lipika Goyal, MD, Medical Oncologist, Massachusetts General Hospital.

Utilization of Radiation Therapy and Trans-Arterial Radioembolization Over Time for Intrahepatic Cholangiocarcinoma in the Unites States

The Radiation Oncologist members are working together to explore changes in the utilization of radiation therapy and trans-arterial radioembolization in the treatment of intrahepatic cholangiocarcinoma over time. They are doing this project in a partnership with Komodo Health, who has the technology for mapping patients’ healthcare journey.

The Principal Investigator is Eugene Koay, MD, Radiation Oncologist at MD Anderson Cancer Center.

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.

Development of Various CCA Subtypes Organoids

The ICRN members are working together to develop 50 viable CCA organoids from biopsy or surgically resected fresh tissue samples in a partnership with Tempus. All ICRN members who are working in an institution which has an organoid laboratory facility are able to participate.

The Principal Investigator is Flavio Rocha, MD, Surgical Oncologist at Virginia Mason University.

Cholangiocarcinoma Immune-Competent Cell Line Optimization

The ICRN physicians and scientists are working together in a multi-institutional, international, translational project to validate Asian and US CCA immune-competent cell lines; they started the first iteration of drug testing aiming to find a novel effective drug combination.

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

We encourage current ICRN members who have innovative project ideas to submit a proposal to the ICRN Executive Committee.

The International Cholangiocarcinoma Research Network (ICRN) is a program of the Cholangiocarcinoma Foundation.