NCT02311205

Efficacy and Safety of Concurrent TACE and Sorafenib in Patients With HCC and Extrahepatic Metastasis (COTSOM Study)

A Phase II, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Concurrent Conventional TACE and Sorafenib in Patients With Hepatocellular Carcinoma and Extrahepatic Metastasis (COTSOM Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II, prospective, open-label, single arm, single center study of the efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the 55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be included. On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Repeated on-demand TACE and sorafenib should continue until the criteria for treatment discontinuation are met. After initiation of sorafenib combination treatment, patients will be seen and will perform routine examination at week 4 and, after then routine examination will be followed every 6 ± 2 weeks.

Detailed description

This is a single center, single arm, prospective, phase II study in patients with metastatic HCC. A total of 55 patients with HCC and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be enrolled. On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Safety will be evaluated every 6 ± 2 weeks after initial TACE and closed monitoring at unscheduled visit will be done as well. The efficacy of TACE will be evaluated every 6 ± 2 weeks after each session of TACE using dynamic CT or MRI. Performance of repeated TACE will be decided based on the findings of follow-up CT, patients' liver function and performance status, within 6 ± 2 weeks of the previous TACE. Patients with no residual viable tumors after previous TACE who are not indicated for further TACE are evaluated with routine examination and imaging studies every 6 ± 2 weeks. Safety should be evaluated on an ongoing basis and within 3 days of next TACE. All eligible patients will be given sorafenib (initially 400mg po bid) on day 3-7 after the first or every session of TACE, and sorafenib will be stopped one day before each TACE. Sorafenib will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Treatment failure will be judged by the evaluation of intra- or extrahepatic lesion separately. TACE failure is defined as when TACE/transarterial chemo-lipiodolization (TACL) has no more benefit by clinical assessment which is judged clinically by one investigator and/or the patient is not more eligible because of worsening of ECOG PS or liver function. Detailed criteria for stopping TACE will be clarified in below. Sorafenib failure will be evaluated by modified RECIST applied to the extrahepatic lesion, and sorafenib will be stopped when progressive disease (PD) by mRECIST for extrahepatic lesion is indicated and clinical benefit of TACE is not expected for intrahepatic lesion. As long as TACE is evaluated to be beneficial and planned to be performed by investigator, sorafenib could be continued if side effect is tolerable. When any of the treatment discontinuation criteria is met, test treatment will be stopped. Survival and post-treatment information will be collected at 1-3 months intervals after the last study visit until the endpoint of death, or until the subject has become lost to follow-up or until study termination by Principal Investigator. Additional palliative anti-cancer therapies such as cytotoxic chemotherapy and TACL without gelfoam embolization and palliative radiation therapy will be allowed and recorded.

Conditions

• Hepatocellular Carcinoma
• Metastasis

Interventions

Type	Name	Description
PROCEDURE	Conventional Transarterial Chemoembolization (TACE)	On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.
DRUG	sorafenib	Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2014-12-08
• Last updated: 2017-12-18

Locations

1 site across 1 country: South Korea