Hoosier Cancer Research Network investigators recently presented abstracts during the 2021 Gastrointestinal Cancers Symposium. The abstracts included a poster featuring the HCRN GI14-198 study, led by Walid Shaib, MD, of Winship Cancer Institute at Emory University, and a trials in progress poster featuring HCRN GI19-405, led by Aiwu Ruth He, MD, of Georgetown University Lombardi Comprehensive Cancer Center.

GI14-198, a phase II randomized, double-blind study of mFOLFIRINOX plus ramucirumab (Arm A) versus mFOLFIRINOX plus placebo (Arm B) in advanced pancreatic cancer patients, demonstrated that the addition of ramucirumab to mFOLFIRINOX did not improve progression free survival, response rate, or overall survival as initial therapy for metastatic pancreatic cancer. FOLFIRINOX/ramucirumab was well tolerated in treating pancreatic adenocarcinoma. The study completed full accrual within the planned time. A total of 86 subjects were enrolled, and 82 were eligible (42 in Arm A, and 40 in Arm B).

The multi-institution study enrolled subjects at eight participating institutions and sites, including Winship Cancer Institute of Emory University, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, the Sidney Kimmel Cancer Center at Thomas Jefferson University, Nebraska Methodist Hospital, Gettysburg Cancer Center, Mayo Clinic in Arizona, Community Healthcare System in Munster, Ind., and University of Louisville James Graham Brown Cancer Center.

Authors include: Walid Labib Shaib, Manali Rupji, Tina Ashley Khair, Erwin L. Robin, Bassel F. El-Rayes, Timothy K. Huyck, Yuan Liu, Mohamad Bassam Sonbol, and Tanios S. Bekaii-Saab.

See abstract.

GI19-405, a randomized phase II study of atezolizumab and bevacizumab with Y90 TARE in patients with unresectable hepatocellular carcinoma, is currently enrolling subjects. The study compares Y90 TARE and bevacizumab plus atezolizumab with Y90 alone in patients with unresectable intermediate-stage HCC (iHCC).

The primary study objective is to assess and compare the progression-free survival (per mRECIST 1.1) of patients in each arm. The main secondary objective is to determine the safety and tolerability (CTCAE v5) of TARE combined with atezolizumab and bevacizumab in patients with HCC. Researchers plan to assess the safety of TARE with bevacizumab and atezolizumab in the first 10 patients randomized to Arm B for two cycles. If there are no grade ≥ 3 unexpected toxicities possibly, probably, or definitely related to combined TARE plus bevacizumab plus atezolizumab, the study will continue to enroll 128 patients in total. The study is currently open to enrollment at the Georgetown Lombardi Comprehensive Cancer Center, and more sites will open to enrollment soon.

Authors include: Aiwu Ruth He, Alexander Y. Kim, Beau M Toskich, Kabir Mody, Kevin Kim, Stacey Stein, Lipika Goyal, Thomas Adam Abrams, Daniel Brown, Laura Williams Goff, Richard D. Kim, Nainesh Parikh, Tyler Sandow, Daniel Johnson, Renuka V. Iyer, Michael Petroziello, Smitha S. Krishnamurthi, Charles Martin, Yixing Jiang, and Nabeel Akhter.

See abstract.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.