Liver cancer trial HE2 opens across Canada

The HE2 clinical trial is now open to enrollment and will investigate whether adding an oral anti-angiogenic drug to an existing intravenous immunotherapy combination is more effective than the immunotherapy combination alone for people with liver cancer who have not received prior treatment.

Hepatocellular carcinoma (HCC) is a deadly cancer with limited survival on current systemic treatments. Although there are regimens available, outcomes remain suboptimal. This trial seeks to improve survival for patients with advanced HCC by leveraging a synergistic approach between current treatments.

“We hypothesize that combining the immunotherapy with the anti-angiogenic drug will offer superior efficacy,” says study co-chair Dr. Vincent Tam, Associate Clinical Professor at the University of Calgary and medical oncologist at the Arthur J. E. Child Comprehensive Cancer Centre. “This combination is based on preclinical and clinical data suggesting that anti-angiogenic agents can reduce immunosuppression, enhancing immunotherapy's effects.”

Earlier research has shown that the addition of the oral anti-angiogenic drug can help slow disease progression and extend survival, while the intravenous immunotherapy combination has been shown to extend survival. The HE2 trial will explore whether combining all three drugs can further improve outcomes for patients with liver cancer.

“We hope that adding on the relative known advantages of the pill therapy will complement the recognized benefits of the IV therapy. And this could result in more patients with advanced HCC benefiting initially and then remaining well longer on a safe drug regimen," says Dr. Jennifer Knox, study co-chair and medical oncologist at UHN Princess Margaret Cancer Centre.

This trial is open to adults with confirmed liver cancer who have not previously received drug treatment for their disease. Participants will be randomly assigned to receive either the standard two-drug treatment or the new three-drug combination. 

"I am genuinely excited about this study,” says Gastrointestinal Disease Site Committee patient representative Haydn Bechthold. “Investigating new drug combinations like this gives patients hope for more time and more options, and I am optimistic that HE2 could be a meaningful step toward better outcomes.”

To learn more:

• HE2 information >
• HE2 information for members > 

Link to clinicaltrials.gov NCT06880523: A Phase II Study of STRIDE (durvalumab + tremelimumab) with Lenvatinib versus STRIDE Alone in Patients with Unresectable Hepatocellular