Trial · NCT04476329
Optimization for Regorafenib in HCC
NCT04476329, Phase 2, Terminated, SC Liver Research Consortium, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimization for Regorafenib in HCC. Trials, record NCT04476329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04476329
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization for Regorafenib in HCC
- NCT number
- NCT04476329
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- SC Liver Research Consortium, LLC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Regorafenib 40 MG
- First posted
- 2020-07-20
- Last updated
- 2021-12-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 24 months | The primary objective is to evaluate whether, or not, an 80 mg/day starting dose of regorafenib that escalates weekly by 40 mg until 160 mg/day is non-inferior compared to the FDA approved labeling 160 mg starting dose of regorafenib in terms of Overall Survival in HCC subjects. |
| Secondary | Regorafenib treatment cycles | 24 months | Proportion of patients who complete two cycles of treatment and who intend to initiate Cycle 3 if no progression is noted on the planned 8-week scan |
| Secondary | Tumor Progression | 24 months | Progression-free survival (PFS) per RECIST v1.1 with exploratory analysis of progression-free survival (PFS) per mRECIST where available |
| Secondary | Dosing Patterns | 24 months | Evaluate the dosing schedule of regorafenib treatment, including: cumulative doses received during first and second cycles, duration of treatment (DOT) measured from Cycle 1 Day 1 to the 1 Month Follow-Up 30 days after the last dose of regorafenib, and summary of additional dose patterns or parameters such as the median daily dose for each treatment arm. |
| Secondary | EORTC QOL-C30 Quality of Life Measurements | 24 months | The EORTC QOL-C30 Quality of Life questionnaire contains 30 questions around physical, day-to-day functioning, and side effects experienced measured on a 4 point Likert scale with a response range of "1-not at all," "2-a little bit," "3-quite a bit," and "4-very much." The results between the Arms, particularly for Cycle 1, will be compared. |
| Secondary | Optional CD14-16 cell sub-study | 36 months | An optional sub-study, collect and hold blood samples from 100 subjects for analysis of mononuclear cells (CD14, 15 \& 16 cells) and other potential biomarkers at a to-be-determined time point after completion of the study. |
| Secondary | FACIT FACT-Hep Quality of Life Measurements | 24 months | The FACT-Hep Quality of Life questionnaire contains 46 questions around physical, social/family, emotional, day-to-day functioning, and side effects experienced measured on a 5 point Likert scale with a response range of "0-not at all," "1-a little bit," "3-somewhat," "4-quite a bit," and "5-very much." The results between the Arms, particularly for Cycle 1, will be compared.. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04476329
GET https://conductscience.org/api/trials/v1/NCT04476329/registered