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NCT03937830 · ClinicalTrials.gov registry record · Phase 2
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma
A Phase 2 study of Hepatocellular Carcinoma and Hepatocellular Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03937830: Active Phase 2 study of Hepatocellular Carcinoma and Hepatocellular Cancer, sponsored by National Cancer Institute (NCI).
NCT03937830 is a Phase 2 study of Hepatocellular Carcinoma and Hepatocellular Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03937830, a Phase 2 study of Hepatocellular Carcinoma and Hepatocellular Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer. Objective: To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE. Eligibility: Adults ages 18 and older with intermediate or advanced HCC Design: Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and/or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach. Participants will get the study drugs in 21-day cycles: Two treatment drugs will be injected into a vein every 3 weeks. Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study. Participants may need to repeat some of the screening tests throughout the study. Participants may have to stop taking some of their cancer treatment drugs during the study. Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable.
Primary Outcome
Proportion of participants with advanced HCC BCLC stage B that have progressive disease after 6 months
Conditions Studied
Interventions
- DRUG durvalumab
- DRUG Tremelimumab
- DRUG bevacizumab
- DRUG Doxorubicin-Eluting Beads
- PROCEDURE TACE
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03937830 still lists
NCT03937830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which durvalumab is the first listed.
NCT03937830 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03937830 about?
NCT03937830 is a clinical study titled "Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma". Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer. Objec...
What is the current status of trial NCT03937830?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-03-10. Estimated completion is 2027-12-31.
What conditions does trial NCT03937830 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Hepatocellular Cancer, Metastatic Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03937830?
The interventions under investigation include: durvalumab (DRUG), Tremelimumab (DRUG), bevacizumab (DRUG), Doxorubicin-Eluting Beads (DRUG), TACE (PROCEDURE).
Who is sponsoring clinical trial NCT03937830?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03937830 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03937830's enrollment target sits among peer trials
27 115th of 145 higher than 31 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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