An observational study in Liver Neoplasms, sponsored by Bayer. Completed at 37 sites in 21 countries. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by Bayer · Observational
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Among 15 studies in Liver Neoplasms by Bayer — none open to participants now, none under way, none of them phase 3. Liver Neoplasms · Bayer.
Among the 15 studies in Liver Neoplasms by Bayer, this one is the only one that started in 2017, is one of 7 observational ones, and was the 12th registered.
1,346 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.
Browse Liver Neoplasms studies →None of the 15 studies in Liver Neoplasms by Bayer is open now. The open studies under Liver Neoplasms, anywhere →
Of the 243 Liver Neoplasms studies recruiting now, 137 (56%) set no upper age limit and 69 (28%) stop at 75 or younger; 14 take children under 18; 34 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,010 is above the median of 200 across 343 observational studies indexed under Liver Neoplasms.
Median enrollment 178 across the 8 interventional studies, 120 across the 7 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Liver Neoplasms by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Source population of the study are patients with unresectable hepatocellular carcinoma. Patients with this condition are mostly managed at specialist centers and cancer hospitals. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. Physicians will be asked to sample consecutive patients whenever possible to avoid selection bias and thus increase the likelihood of representativeness.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
Drug: Regorafenib (Stivarga, BAY73-4506)
As per the treating physicians discretion
Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs). Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.
Time frame: Up to 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time (days) from the start of regorafenib treatment to the date of death, due to any reason. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up
Time frame: Up to 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time (days) from the start of regorafenib treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented
Time frame: Up to 24 months
Time to progression (TTP)
Time to progression (TTP) is defined as the time (days) from the start of regorafenib treatment to the first documented disease progression
Time frame: Up to 24 months
Best overall tumor response (ORR)
Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standard
Time frame: Up to 24 months
Duration of regorafenib treatment
Duration of regorafenib treatment, defined by the time interval from the start of regorafenib treatment to the day of permanent discontinuation of regorafenib (including death)
Time frame: Up to 24 months
Plan to share: Undecided — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Ran from Sep 2017 to primary completion in Jan 2022, 52 months.
Of 160 observational studies under Liver Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 172. This study's 52 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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