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NCT04430452 · ClinicalTrials.gov registry record · Phase 2
Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
A Phase 2 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, sponsored by Mary Feng, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04430452: Recruiting Phase 2 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, sponsored by Mary Feng, MD.
NCT04430452 is a Phase 2 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by Mary Feng, MD. The registered enrollment target is 21 participants, below the 86-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04430452, a Phase 2 study of Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by Mary Feng, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.
Primary Outcome
Response is defined per Response Evaluation Criteria in Solid Tumors 1.1 as a complete response (CR) or Partial Response (PR) (CR+PR=ORR) excluding radiation therapy-treated lesions. Response will be assessed after participants complete 5 fractions of standard palliative radiotherapy (RT). Proportion of participants with a confirmed response and corresponding exact confidence intervals will be reported by Arm. Participants with unevaluable or unknown response status will be considered non-respon
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- RADIATION Hypofractionated Radiation Therapy
- BIOLOGICAL Tremelimumab
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-02-04 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 2 |
What NCT04430452 shows while recruiting
NCT04430452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 86-participant average among 16 other Advanced Hepatocellular Carcinoma trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Advanced Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT04430452 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04430452 about?
NCT04430452 is a clinical study titled "Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma". This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or ...
What is the current status of trial NCT04430452?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-02-04. Estimated completion is 2029-07-31.
What conditions does trial NCT04430452 study?
This clinical trial studies the following conditions: Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IVA Hepatocellular Carcinoma AJCC V8.
What interventions are being tested in trial NCT04430452?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Hypofractionated Radiation Therapy (RADIATION), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04430452?
This trial is sponsored by Mary Feng, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04430452 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04430452's enrollment target sits among peer trials
21 15th of 16 higher than 2 of 16 other Advanced Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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