Shishir Maithel, MD
Professor, Surgery
Research Program
- Translational Research in Malignancy (TRIM)
Cancer-Focused Research
I have initiated, organized, led, and served as the National Principal Investigator of ten multi-institutional research collaborations focused on the study of a wide array of diseases including biliary tract malignancies, gastric cancer, pancreas cancer, hepatocellular cancer, sarcoma, and neuroendocrine tumors. This process and model for collaborative research that I developed has been very productive and successful, and thus has been emulated by several investigators across the country, all under my direct mentorship. The strength of these multi-institutional efforts afforded the platform and foundation for me to seamlessly integrate into the national clinical trials network (NCTN) and cooperative group mechanism. Over the past 10 years, I have rapidly ascended to leadership positions in the clinical trials network, serving as the Chair of the GI Surgery Working Group for the Eastern Cooperative Oncology Group (ECOG-ACRIN), Co-Chair of the ECOG-ACRIN Surgery Committee, and a contributing member of the NCI Hepatobiliary Task Force. I am the Study Chair of an NCTN NCI-funded Randomized Controlled Phase II/III trial on the management of incidental gallbladder cancer (EA2197). Given my passion for mentorship and sponsorship, I used what I learned during the process of EA2197 to mentor and guide other Surgical Oncologists around the country in their own concept proposals. The success of my mentees has been applauded and has earned me the reputation as a national surgical mentor in conducting clinical trials, leading me to also serve as Co-Chair of four other NCI-funded randomized trials (EA7201, EA2192, EA2222, EA2234), with two others far along in development. I have focused my own clinical trial efforts to improve the care of patients with biliary tract malignancies, namely gallbladder cancer and cholangiocarcinoma. I became an active member of the Cholangiocarcinoma Foundation in 2015 and subsequently was appointed Co-Chair of the Data Committee in the International Cholangiocarcinoma Research Network and a member of the Scientific Medical Advisory Board. Through this Foundation, I have developed a strong network of multi-disciplinary experts in the management of cholangiocarcinoma. Leveraging these connections, I successfully led and completed the Phase II multi-institutional NEO-GAP investigator-initiated industry-funded clinical trial. This ‘forward thinking' concept established the safety and feasibility of administering an aggressive novel triple drug chemotherapy regimen in the neoadjuvant space prior to resection. The treatment landscape for cholangiocarcinoma has made great strides over the past five years, capitalizing on the incorporation of immunotherapy, but more importantly, identifying and targeting actionable alterations that are present in these tumors. Given the success of these treatment strategies in the advanced disease setting, I have been a national advocate for bringing these regimens to patients with early-stage disease. Similar to what I did with the NEO-GAP clinical trial, I am proposing a multi-institutional Phase II trial that will determine the safety and feasibility of performing NGS and administering targeted therapy and immunotherapy in the neoadjuvant setting to patients with early-stage resectable intrahepatic cholangiocarcinoma.