To begin each module, results of interactive audience polling using networked iPads will be juxtaposed with the findings from a survey comprising case-based and related management questions completed by 25 clinical investigators prior to the meeting. Each faculty member will then deliver a presentation reviewing recently published research data and ongoing clinical trials related to the topics and questions addressed via the surveys. After each presentation, moderated panel discussion will take place to generate other relevant perspectives and dialogue.

MODULE 1: First-Line Systemic Therapy for Patients with Unresectable Hepatocellular Carcinoma (HCC) — Dr Finn

• Design of, eligibility criteria for and key efficacy findings from the Phase III REFLECT study comparing lenvatinib to sorafenib as first-line therapy for unresectable HCC
• Frequency of treatment-related side effects (eg, hypertension, hand-foot syndrome, decreased appetite, proteinuria), dose delays and discontinuations associated with lenvatinib and sorafenib in the REFLECT trial
• FDA approval of lenvatinib as first-line therapy for unresectable HCC; patient selection for its use in routine practice
• Results from the Phase III CheckMate 459 trial evaluating nivolumab as first-line treatment for advanced HCC; clinical and research implications
• Biologic rationale for, early trial data with and FDA breakthrough therapy designation for atezolizumab/bevacizumab as first-line therapy for advanced HCC
• Available efficacy and safety results from the Phase III IMbrave150 trial documenting the benefit of atezolizumab in combination with bevacizumab as first-line therapy for advanced HCC

MODULE 2: Available Data with and Patient Selection for Anti-angiogenic Therapy for Progressive Metastatic HCC — Dr Zhu

• Key factors (eg, performance status, liver function, alpha-fetoprotein [AFP] level, prior therapy) influencing the selection of treatment for patients who experience disease progression after first-line therapy
• Design, eligibility criteria and key efficacy and safety outcomes from the Phase III RESORCE trial comparing regorafenib to best supportive care for patients with disease progression on sorafenib; optimal starting dose of regorafenib as second-line therapy
• Major efficacy and tolerability findings from the Phase III CELESTIAL trial comparing cabozantinib to placebo for patients with HCC who have experienced disease progression on sorafenib; outcomes for patients who had received more than 1 systemic anticancer regimen
• FDA approval and off-protocol role of cabozantinib in the management of progressive HCC
• Clinical significance and frequency of elevated AFP in patients with advanced HCC; proportion of individuals with advanced HCC with AFP-high (≥400 ng/mL) disease
• Key findings from the Phase III REACH-2 study of ramucirumab for patients with progressive HCC and elevated AFP levels; recent FDA approval of ramucirumab and patient selection for this approach

MODULE 3: Published Data with and Appropriate Integration of Immune Checkpoint Inhibitors into the Care of Patients with Progressive Metastatic HCC — Dr El-Khoueiry

• Clinical factors guiding the use of immunotherapy versus targeted therapy for patients experiencing disease progression on first-line sorafenib or lenvatinib (eg, Child-Pugh score, disease-free interval, tyrosine kinase inhibitor tolerability)
• Long-term efficacy and safety from the Phase I/II CheckMate 040 study of nivolumab for patients with advanced HCC who refused or experienced progressive disease on sorafenib
• Key efficacy and safety results from the Phase II KEYNOTE-224 trial evaluating pembrolizumab for patients with advanced HCC whose disease progressed on or who could not tolerate sorafenib; accelerated FDA approval of pembrolizumab for patients with HCC who have previously received sorafenib
• Available data from the Phase III KEYNOTE-240 trial evaluating pembrolizumab versus best supportive care for patients with advanced HCC after disease progression on sorafenib; effect, if any, on future use
• Autoimmune toxicity profile of immune checkpoint inhibitors in patients with HCC compared to those with other diseases; special considerations for patients with extensive liver disease, hepatitis B or C, prior liver transplant, et cetera

MODULE 4: Novel Approaches Under Investigation for Advanced HCC — Prof Galle

• Results from the Phase Ib KEYNOTE-524 trial/Study 116 evaluating pembrolizumab in combination with lenvatinib as first-line treatment for advanced unresectable HCC not amenable to locoregional treatment; FDA breakthrough therapy designation and developmental plans
• Available safety and efficacy findings with and ongoing evaluation of combined anti-PD-1/PD-L1 and anti-CTLA-4 antibodies in HCC (eg, nivolumab/ipilimumab, durvalumab/tremelimumab)
• FDA acceptance of supplemental Biologics License Application and priority review status for nivolumab with ipilimumab for advanced HCC previously treated with sorafenib
• Active Phase III trials attempting to improve outcomes over standard biologic therapy for patients with newly diagnosed, advanced HCC (eg, LEAP-002, COSMIC-312, HIMALAYA)
• Other novel agents and strategies under late-stage investigation in advanced HCC

MODULE 5: Current and Future Management of Advanced Biliary Tract Cancers — Dr Abou-Alfa

• Heterogeneity of advanced biliary tract cancers; variability of clinical presentation, outcomes and available treatments based on primary tumor location (intrahepatic bile ducts versus extrahepatic bile ducts versus gallbladder)
• Spectrum of molecular alterations among advanced biliary tract cancers; utility of next-generation sequencing to identify actionable molecular abnormalities
• Frequency of IDH mutations in patients with advanced cholangiocarcinoma and early data with novel agents targeting these abnormalities
• Results from the Phase III ClarIDHy study evaluating the IDH1 inhibitor ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation
• Biologic rationale supporting FGFR inhibition as a rational therapeutic strategy for patients with metastatic cholangiocarcinoma
• Findings from the Phase II FIGHT-202 trial of the selective FGFR inhibitor pemigatinib for patients with advanced or surgically unresectable cholangiocarcinoma and an FGFR2 translocation for whom at least 1 previous treatment had failed; FDA acceptance for priority review of pemigatinib and potential role in clinical practice
• Design, eligibility criteria and estimated completion date for the Phase III FIGHT-302 study of pemigatinib versus gemcitabine/cisplatin as first-line therapy for unresectable or metastatic cholangiocarcinoma with an FGFR2 rearrangement
• Available clinical trial experience with other targeted therapeutic approaches (eg, infigratinib, erdafitinib, dabrafenib/trametinib) and anti-PD-1/PD-L1 antibodies in advanced biliary tract cancers