Study to Collect more detailedinformation concerning TACE treatment followed by Sorafenib for hepatocellularcarcinoma (HCC) or without sorafenib after TACE enabling us to evaluate thetime to meet criteria for TACE non-eligibility

Phase 4

Completed

• Conditions: Health Condition 1: null- Carcinoma, Hepatocellular

• Registration Number: CTRI/2014/12/005310
• Lead Sponsor: Bayer pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-07-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survivalTimepoint: Time Frame: Up to 3 years

Secondary Outcome Measures

Name	Time	Method
umber of patients with TEAEs (treatment emergent adverse events)Timepoint: Time Frame: Up to 3 years <br/ ><br> <br/ ><br>;Duration of treatmentTimepoint: Time Frame: Up to 3 years;Overall survival from initial TACETimepoint: Time Frame: Up to 3 years;Progression-free survival from initial TACETimepoint: Time Frame: Up to 3 years;Time to progression from initial TACETimepoint: Time Frame: Up to 3 years;Tumor response according to mRECIST criteriaTimepoint: Time Frame: Up to 3 years