Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorJu Hyun Shim
About this trial
The purpose of this clinical trial is to evaluate the efficacy and safety of regorafenib as a subsequent therapy for patients with hepatocellular carcinoma (HCC) who have failed prior lenvatinib treatment. This investigational study aims to assess the therapeutic benefits and safety profile of regorafenib in patients whose disease has progressed following the use of lenvatinib, a targeted therapy for hepatocellular carcinoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form.
Age ≥ 19 years at the time of signing the informed consent form.
Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines.
Patients with unresectable HCC who have experienced disease progression or treatment discontinuation due to toxicity during prior treatment with lenvatinib.
Disqualifiers
Albumin-bilirubin (ALBI) grade 3.
Fibrolamellar carcinoma or sarcomatoid carcinoma.
Prior treatment with regorafenib.
History of allogeneic stem cell transplantation or solid organ transplantation.
Trial design
Design model
Single group
Treatments tested in this trial
Regorafenib (BAY 73-4506)
Drug"Participants with unresectable hepatocellular carcinoma who have failed prior lenvatinib treatment will receive oral regorafenib. The starting dose for Cycle 1 is 160 mg once daily for patients with Child-Pugh class A, and 120 mg once daily for patients with Child-Pugh class B. From Cycle 2 onwards, regorafenib will be administered at the maximum tolerated dose on a schedule of 3 weeks on and 1 week off (28-day cycle). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: RegorafenibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression free survival
Tumor assessments every 12 weeks (±7 days) after treatment discontinuation without documented progression until progression, death, or end of follow-up, whichever occurs first.
Time frame
From date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.Secondary outcomes
1
Overall survival
Survival follow-up assessments are conducted every 12 weeks (±7 days) after treatment discontinuation due to disease progression or withdrawal until death or end of follow-up.
Time frame
From date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.2
time to progression
Baseline and scheduled tumor imaging assessments every 12 weeks (±7 days) thereafter (date of documented PD per RECIST v1.1).
Time frame
From treatment initiation until first documented progression or start of subsequent systemic anticancer therapy, assessed up to 36 months.3
objective response rate
Assessment of Best Overall Response (CR/PR) at scheduled tumor imaging time points (every 12 weeks ±7 days) from treatment initiation until first PD or start of subsequent systemic anticancer therapy.
Time frame
From treatment initiation until first documented progression or start of subsequent systemic anticancer therapy, assessed up to 36 months.4
disease control rate
Assessment of Best Overall Response (CR/PR/SD) at scheduled tumor imaging time points (every 12 weeks ±7 days) from treatment initiation until first PD or start of subsequent systemic anticancer therapy.
Time frame
From treatment initiation until first documented progression or start of subsequent systemic anticancer therapy, assessed up to 36 months.Sponsors and contacts
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Ju Hyun Shim
Lead sponsor
Asan Medical Center
Sponsor institution
Boryung Pharmaceutical Co., Ltd
Collaborator
Samsung Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
National Cancer Center, Korea
Collaborator
Hanyang University Guri Hospital
Collaborator
Source ClinicalTrials.gov
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