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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 is a Phase 3 study that was terminated before completion, run by Translational Research in Oncology. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04777851
The ClinicalTrials.gov registry entry for NCT04777851 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Translational Research in Oncology, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Regorafenib in combination with pembrolizumab is the first listed.
NCT04777851 reports 0 study locations.
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.
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