Could Your Patients Benefit? New Trials in Noncolorectal GI Cancer

Helen Leask

September 29, 2022

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 FDA 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, North Carolina, has begun recruitment, and centers in Phoenix, Arizona, and Chicago, Illinois, 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

Untreated metastatic pancreatic ductal adenocarcinoma. Adult patients with this disease can join a randomized, blinded, phase 2/3 study testing polyamine inhibitor SBP-101 (diethyl dihydroxyhomospermine) in combination with standard-of-care therapies gemcitabine (Gemzar) and nab-paclitaxel (Abraxane). Polyamine metabolism is central to cellular growth and proliferation.

SBP-101 inhibited pancreatic tumor growth in its phase 1 trial. In the phase 2/3 study, all participants will receive gemcitabine and nab-paclitaxel for up to 3 years; those in the experimental group will also receive SBP-101. The trial began recruiting an initial 150 participants in Arkansas, Texas, and Wisconsin in August, with the option to recruit additional patients on the basis of an interim analysis when 104 patients have either died or the disease has progressed. The primary outcome is overall survival, and the secondary outcome is quality of life. More details at

Previously treated unresectable, locally advanced or metastatic liver cancer. People with this type of liver cancer are eligible for a randomized phase 2 study to determine whether survival can be improved by combining the immunotherapy atezolizumab with a targeted therapy — carbozantinib or lenvatinib. All participants will take carbozantinib or lenvatinib capsules daily for up to 3 years. Half the group will also receive intravenous atezolizumab every 3 weeks. The University Medical Center New Orleans started recruiting 122 participants in May, and study sites are gearing up in eight more states. Overall survival and progression-free survival are primary endpoints; quality of life will not be tracked. More details at

All trial information is from the National Institutes of Health US National Library of Medicine (online at

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