NCT07514455: RECOMEND

Regorafenib After Treatment Failure of First Line Immune Checkpoint Inhibitor Treatment in Advanced Hepatocellular Carcinoma Patients

Not yet recruiting Phase 2 Last updated 7 April 2026

What this trial tests

Phase 2 trial testing Regorafenib (BAY 73-4506) in Carcinoma, Hepatocellular in 20 participants. Not yet recruiting.

Timeline

15 March 2026

Primary endpoint
31 May 2028

30 June 2028

Quick facts

Lead sponsor	Ju Hyun Shim
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 March 2026
Primary completion	31 May 2028
Estimated completion	30 June 2028
Sites	1 location across South Korea

Drugs / interventions tested

• Regorafenib (BAY 73-4506) — full drug profile →

Conditions studied

• Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
• Hepatic Insufficien — all drugs for Hepatic Insufficien →
• Disease Progression — all drugs for Disease Progression →
• Treatment Failure — all drugs for Treatment Failure →

Sponsor

Ju Hyun Shim

Who can join

Adults 19 to 80, any sex, with Carcinoma, Hepatocellular or Hepatic Insufficien. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immune checkpoint inhibitor (ICI)-based regimens (atezolizumab+bevacizumab, durvalumab+tremelimumab, nivolumab+ipilimumab) are now a first-line standard for advanced hepatocellular carcinoma (HCC). For Child-Pugh (CP) A patients, regorafenib, cabozantinib, and ramucirumab are approved second-line agents, but there is no approved second-line systemic therapy for CP-B. In CP-B historical controls treated with best supportive care, median progression free survival (PFS) was \~1.4 months in a REACH trial subgroup analysis and \~1.9 months in a CELESTIAL trial subgroup analysis. Regorafenib demonstrated benefit as a post-sorafenib second-line therapy in CP-A patients in the RESORCE trial, but prospective evidence in CP-B is lacking. A multicenter retrospective study of CP-B patients receiving second-line regorafenib after sorafenib reported a median PFS of 1.8 months, and prospective data after ICI-based first-line therapy are not available.

This study will evaluate the efficacy and safety of regorafenib as second-line therapy in CP-B patients with disease progression after first-line ICI-based treatment. The primary objective is to demonstrate superiority over historical controls, with PFS as the primary endpoint.

After written informed consent, all participants will receive regorafenib. Regorafenib will be administered at 120 mg orally once daily at the same time each day, after a meal with water, for 3 consecutive weeks followed by 1 week off (4-week cycle). Treatment must start within 3 days after screening and will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. After treatment discontinuation, patients will be followed every 12 week (+/-7 days) for survival status and subsequent anticancer therapies, and survival follow-up will continue for at least 12 months after enrollment of the last participant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.