Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

Carcinoma, Hepatocellular Clinical Trial

— OPTIMIS  

Official title:

OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933945
• Other study ID #: 16560
• Secondary ID: NX1301
• Status: Completed
• Start date: October 28, 2013
• Est. completion date: November 10, 2017

Study information

• Verified date: November 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1676
• Est. completion date: November 10, 2017
• Est. primary completion date: July 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.

• Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.

• Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.

• Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)

• Patients must have signed an informed consent form

• Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

• Patients who have received TACE in the past but the data about TACE required in this protocol are not available

• Patients who received any systemic anti-cancer therapy prior to the first TACE

• Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy

• Hospice patients

• All contra-indications according to the local marketing authorization should be considered.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• TACE (transarterial chemoembolization)
First treatment for all patients included in the study

Drug:
• Sorafenib (Nexavar, BAY43-9006)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Brazil,  Canada,  China,  Czechia,  Denmark,  Egypt,  France,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Japan,  Kazakhstan,  Korea, Republic of,  Mexico,  Netherlands,  Pakistan,  Poland,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PFS from TACE non-eligibility	PFS from TACE non-eligibility was defined as the time interval from TACE non-eligibility to documented (radiological or clinical) progression or death, whichever came first.	Up to 3 years
Other	TTP from TACE non-eligibility	TTP from TACE non-eligibility was defined as the time interval from TACE non-eligibility to the date of documented progression.	Up to 3 years
Other	Tumor response from time of TACE non-eligibility by mRECIST	Planned to be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable"	Up 3 years
Other	Switch to sorafenib or other systemic and non-systemic cancer therapy	Evaluated according to the categories "Before initial TACE", "After one TACE", "After two TACEs", and "After more than two TACEs"	Up to 3 years
Other	Deviations from recommendations for TACE use	Deviations from recommendations for TACE use in the treatment guidelines for TACE use based on the number of patients for whom the treatment decision for a new TACE was made by the investigator after TACE non-eligibility.	Up to 3 years
Other	Duration of treatment of sorafenib after TACE	Defined as days from the first sorafenib dose to the date of permanent discontinuation of sorafenib plus one	Up to 3 years
Primary	Overall survival (OS)	Defined as time (in days) from time of TACE non-eligibility to death due to any cause. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.	Up to 3 years
Secondary	Overall survival from initial TACE	OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause.	Up to 3 years
Secondary	Progression-free survival (PFS) from initial TACE	PFS from initial TACE was defined as the time interval measured from the day of the first TACE to documented (radiological or clinical) progression or death, whichever came first.	Up to 3 years
Secondary	Time to progression (TTP) from initial TACE	TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression.	Up to 3 years
Secondary	Tumor response according to mRECIST criteria	Tumor response to TACE by modified Response Evaluation Criteria In Solid Tumors (mRECIST) were evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable" by mRECIST for each TACE.	Up to 3 years
Secondary	Duration of TACE treatment	Duration of TACE treatment was defined as the time interval from of the day of first TACE to the date of permanent discontinuation of TACE	Up to 3 years
Secondary	Number of patients with TEAEs (treatment emergent adverse events)	Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.	Up to 3 years
Secondary	TACE unsuitability	TACE unsuitability was determined according to selected guidelines	Up to 3 years
Secondary	Time to TACE non-eligibility	Determined according to the selected guidelines	Up to 3 years
Secondary	Deterioration of liver dysfunction	Deteriorations of liver dysfunction were defined as follow: Deterioration of Child Pugh score (A5, A6, B7, B8, B9); Liver dysfunction reported as AE or deterioration of aspartate aminotransferase, alanine aminotransferase or bilirubin (from Grade 1 to Grade 2-5, from Grade 2 to 3-5, Grade 3 to Grade 4 or 5); Any liver related adverse events or deterioration of liver related events according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03; Change of liver related laboratory data (aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, prothrombin international normalized ratio [INR])	Up to 3 years
Secondary	OS from initiation of sorafenib	OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause.	Up to 3 years
Secondary	PFS from initiation of sorafenib	PFS from initiation of sorafenib was defined as the time interval measured from the start date of sorafenib treatment to documented (radiological or clinical) progression or death, whichever came first.	Up to 3 years
Secondary	Tumor status at different visits response according to mRECIST	mRECIST: modified Response Evaluation Criteria In Solid Tumors	Up to 3 years
Secondary	Duration of sorafenib treatment	Duration of sorafenib treatment was defined as the time interval from start date of sorafenib treatment to the date of permanent discontinuation of sorafenib treatment (regardless of the reason for discontinuation including death).	Up to 3 years
Secondary	TTP from initiation of sorafenib	TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression.	Up to 3 years

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