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Could your patients benefit? New trials in noncolorectal GI cancer


Several new studies in noncolorectal GI cancers have launched in recent months. Could one of your patients benefit from participating?

Advanced hepatocellular cancer after at least two previous systemic therapies

Adult patients meeting this clinical scenario for whom there are no curative treatment options can join a randomized, blinded, phase 2 study testing the effectiveness of a radio wave device called TheraBionic. This home-administered device drenches the body in a nonthermal electromagnetic field via a spoon-shaped antenna held in the patient’s mouth. TheraBionic received Food and Drug Administration Breakthrough Device designation in 2019, and the device is still experimental.

In the trial, all participants will self-treat in three 1-hour sessions daily for up to 6 months. In the placebo arm, the device will not emit any therapeutic frequencies. Overall survival and quality of life over 6 months are the primary endpoints, and investigators are seeking to enroll 166 participants. Wake Forest Baptist Comprehensive Cancer Center in Winston-Salem, N.C., has begun recruitment, and centers in Phoenix and Chicago will begin recruiting soon. More details at

Unresectable nonmetastatic hepatocellular carcinoma

Individuals with this type of liver cancer who have not received any treatment are being recruited for a randomized, phase 2 study of a targeted radiation treatment called TheraSphere. The study will assess whether the effectiveness of TheraSphere can be boosted with immunotherapy.

TheraSphere was approved by the FDA in March 2021. It consists of yttrium-90 encased in millions of microscopic glass spheres that, after infusion, lodge exclusively in the tumor site.

All patients in the trial will receive a single dose of TheraSphere. People in the immunotherapy arm will also receive a single intravenous infusion of investigational tremelimumab plus durvalumab (Imfinzi), then monthly infusions of durvalumab for up to 18 months. The study, which opened in Illinois and New York in September, aims to enroll 150 participants. Objective response rate and duration of response are the primary outcomes; overall survival and quality of life are secondary endpoints. More details at

Locally advanced or metastatic unresectable gastric or gastroesophageal-junction (GEJ) cancer

Adults with these types of cancer who have received two or three prior lines of standard treatment for metastatic disease are sought for a nonrandomized, phase 2 trial assessing whether disease progression can be slowed by navicixizumab in combination with paclitaxel (Taxol). Navicixizumab is an experimental antiangiogenic therapy that has been tested so far in a small phase 1 trial of patients with refractory gynecologic, breast, and GI cancers.

In this phase 2 trial, patients with gastric or GEJ cancer will receive navicixizumab infusions every other week for up to 1 year, as well as weekly paclitaxel infusions. The study opened in August in sites in Arkansas, Georgia, Louisiana, New York, Ohio, and Tennessee. It aims to enroll 180 participants who have a range of solid tumors. The primary outcomes are overall response rate and progression-free survival; overall survival is a secondary outcome. Quality of life will not be assessed. More details at


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