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NCT04777851 · ClinicalTrials.gov registry record · Phase 3
Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7
A Phase 3 study, sponsored by Translational Research in Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT04777851: Clinical Trial Phase 3 study, sponsored by Translational Research in Oncology.
NCT04777851 is a Phase 3 study that was terminated before completion, run by Translational Research in Oncology. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04777851, a Phase 3 study, was terminated before completion, sponsored by Translational Research in Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) 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 pembrolizumab * Control arm: Transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) 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.
Primary Outcome
PFS, defined as the time (in months) from the date of randomization until the date of progressive disease (PD) or death due to any cause, whichever occurs first. PD will be assessed locally by the Investigator using mRECIST.
Interventions
- DRUG Regorafenib in combination with pembrolizumab
- PROCEDURE Loco-regional therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2023-10-11 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 3 |
Why NCT04777851 stopped before completion
NCT04777851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Regorafenib in combination with pembrolizumab is the first listed.
NCT04777851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04777851 about?
NCT04777851 is a clinical study titled "Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7". REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) for the first-line treatment of hepatocellular carcinoma (HCC o...
What is the current status of trial NCT04777851?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2023-10-11. Estimated completion is 2026-02-26.
What interventions are being tested in trial NCT04777851?
The interventions under investigation include: Regorafenib in combination with pembrolizumab (DRUG), Loco-regional therapy (PROCEDURE).
Who is sponsoring clinical trial NCT04777851?
This trial is sponsored by Translational Research in Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04777851's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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