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ASCO GI 2026 | Phase 2 trial of cabozantinib, ipilimumab, nivolumab, and TACE in HCC
Nadine Abi-Jaoudeh, MD, University of California, Irvine, CA, comments on a Phase II study (NCT04472767) evaluating cabozantinib with ipilimumab and nivolumab plus transarterial chemoembolization in patients with liver-limited unresectable hepatocellular carcinoma (HCC). The multimodal approach demonstrated encouraging anti-tumor activity with a manageable safety profile. Notably, some patients converted to resectable status and achieved long-term remission following hepatectomy. This interview took place at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, CA.
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Transcript
So this was a study that combined nivolumab plus transarterial tirapazamine embolization, so we’re going to call it TATE, in patients with very advanced HCC that had failed at least one line of immunotherapy. So right now, patients who have failed one line of immunotherapy, there’s no standard of care. And so this is the population we were targeting. What we do is we start them off on nivolumab...
So this was a study that combined nivolumab plus transarterial tirapazamine embolization, so we’re going to call it TATE, in patients with very advanced HCC that had failed at least one line of immunotherapy. So right now, patients who have failed one line of immunotherapy, there’s no standard of care. And so this is the population we were targeting. What we do is we start them off on nivolumab. A week after that, they undergo TACE, or TPZ embolization, but actually it is transarterial chemoembolization with Tirapazamine. Tirapazamine, just for a little bit of background, is a hypoxia-activated agent, which means when it’s in a cell that’s hypoxic, it turns into a free radical that attacks the cell and causes necrosis. And so what we do is we get into the arteries supplying the tumors, we infuse the TPZ, and then we embolize those vessels. One, the embolization shuts down the blood flow, which decreases the oxygen and places those cells into a state of deep hypoxia, which activates the TPZ and also enables the TPZ not to be washed out from the tumor. So once there’s necrosis of the tumors, there’s release of antigens and activation of DENDRIC cells. And so that activates the immune system that’s already been primed by the nivolumab. We’ve seen very encouraging results. This is still a small study. We have 18 evaluable patients. But we’ve noted a 55% mRECIST response rate. The disease control rate by mRECIST is 77%. Five of the patients had extra hepatic disease. Three of those had significant shrinkage of their extra hepatic tumors. and that included adrenal mets, lymph nodes, lung mets, and bone mets. It’s significant because local regional therapies by themselves would not induce a systemic response, and these patients were on immunotherapy and were progressing, and those lesions were growing, but now the combination of the two is resulting in responses that are very encouraging.
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