Regorafenib and Nivolumab Combined Versus TACE in Intermediate-Stage HCC Beyond Up-to-7 (RENOTACE)
Status:
Not yet recruiting
Trial end date:
2025-05-15
Target enrollment:
Participant gender:
Summary
RENOTACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy
and safety of regorafenib and nivolumab (Rego-Nivo) versus transarterial chemoembolization
(TACE) for the first-line treatment of hepatocellular carcinoma (HCC or liver cancer).
Approximately 496 patients in around 80 clinical sites worldwide will be randomized to
receive either:
- Investigational arm: Regorafenib in combination with nivolumab (rego-nivo)
- Control arm: Transarterial chemoembolization (TACE)
In both arms, patients will receive trial treatment until progressive disease, unacceptable
toxicity, deterioration of patient's condition that warrants permanent trial treatment
discontinuation or other treatment discontinuation criteria is met. After trial treatment
discontinuation, subsequent treatment will be administered according to the Investigator's
clinical judgment.
It is hypothesized that combining regorafenib and nivolumab, may be advantageous over
standard treatment at an earlier HCC stage such as the intermediate-stage. This drug
combination was tested previously in pre-treated metastatic gastric and colorectal cancer
(Phase 1b, REGONIVO trial). The 80 mg regorafenib dose had a manageable safety profile and
encouraging antitumor activity (objective tumor response 40 precent) in patients with heavily
pretreated disease. Based on these promising results, the Rego-Nivo combination is being
tested in a number of ongoing clinical trials.
RENOTACE will compare the efficacy and safety of the standard of care approach in patients
with this stage (i.e. TACE) versus Rego-Nivo, for the first-line treatment of
intermediate-stage HCC with beyond up-to-7 criteria. Although there are a number of trials
comparing TACE with TACE in combination with systemic therapy, this will be the first trial
comparing TACE with systemic therapy alone, an approach that could potentially represent a
shift in the management of intermediate-stage HCC.