stop_circleTerminated/Withdrawn
Hepatocellular Carcinoma
Bayer Identifier:
20215
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Use of Sorafenib and/or Regorafenib in liver cancer (hepatocellular carcinoma) subsequent to another systemic first-line treatment
Trial purpose
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).
In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.
In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
3Trial Dates
January 2019 - September 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Many Locations | Many Locations, Germany |
Primary Outcome
- Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditionsdate_rangeTime Frame:Up to 24 months
Secondary Outcome
- Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapydate_rangeTime Frame:Up to 36 months
- Progression free survival (PFS)date_rangeTime Frame:Up to 36 months
- Time to progression (TTP)date_rangeTime Frame:Up to 36 months
- Duration of Nexavar or Stivarga treatmentdate_rangeTime Frame:Up to 36 months
- Tumor response to treatmentEvaluated by the investigator according to the categories “complete response”, “partial response”, “stable disease”, “progressive disease by clinical judgment”, “progressive disease measurement proven”, “unknown” and “not applicable”, and will be analyzed providing absolute and relative frequencies of the tumor status categories.date_rangeTime Frame:Up to 36 months
- Incidence of treatment-emergent adverse events (TEAE)date_rangeTime Frame:Up to 36 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A