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Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma

Study acronym: STRAT-aHCC
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jan 2025 to Nov 15, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2025 to Dec 15, 2026
    • Site details revised
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Sep 10, 2023
    • Study sites: 0 to 1
    v4
  3. Start date: Jan 2023 to Apr 2023v3
  4. Secondary endpoints revised (4)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The present protocol (STRAT-aHCC trial) aims to prospectively evaluate the tolerability, quality of life and efficacy of an alternative regimen of regorafenib in patients with advanced hepatocellular carcinoma (HCC) after progression to first-line. Patients will receive increasing dose of regorafenib in the first 2 treatment cycles (initial dose of 80mg, with weekly increments of 40mg up to 160mg in the first 2 treatment cycles). From the 3rd cycle on, the maximum tolerated dose during the first 2 cycles will be maintained. The maximum tolerated dose will be considered the highest dose in which the patient does not present grade ≥3 adverse events. The primary endpoint is the proportion of evaluable patients completing cycle 4. Radiologic response rate, quality of life, time to progression and overall survival will be evaluated as secondary endpoints.
Trial Details
NCT Number NCT05622136
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Conditions
(from sponsor)		 Liver Cancer, Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular, Liver Neoplasms
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov