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NCT03519997 · ClinicalTrials.gov registry record · Phase 2
A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma
A Phase 2 study of Hepatocellular Carcinoma, sponsored by David Hsieh.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT03519997: Active Phase 2 study of Hepatocellular Carcinoma, sponsored by David Hsieh.
NCT03519997 is a Phase 2 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by David Hsieh. The registered enrollment target is 35 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03519997, a Phase 2 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by David Hsieh.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects must not have received prior systemic therapy for advanced HCC in keeping with the first-line setting of this study.
Primary Outcome
To determine the overall response rate (ORR) defined as the number of complete or partial responses according to RECIST 1.1 divided by the number of evaluable patients treated with combination pembrolizumab and bavituximab in patients with advanced HCC.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Bavituximab
Study Locations (2)
Texas
- Parkland Health & Hospital System - Dallas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 2 |
What the registry record for NCT03519997 still lists
NCT03519997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03519997 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03519997 about?
NCT03519997 is a clinical study titled "A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma". This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects must not have received...
What is the current status of trial NCT03519997?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2018-04-26. Estimated completion is 2026-04-01.
What conditions does trial NCT03519997 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03519997?
The interventions under investigation include: Pembrolizumab (DRUG), Bavituximab (DRUG).
Who is sponsoring clinical trial NCT03519997?
This trial is sponsored by David Hsieh, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03519997 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03519997's enrollment target sits among peer trials
35 103rd of 145 higher than 42 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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.
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