Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib

NCT01217034 | Unknown Phase 2 DMC

• 1 other identifier: JLOG 1001 trial
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.

Conditions

Hepatocellular Carcinoma; Unresectable Hepatocellular Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasm

Keywords

Transcatheter arterial chemoembolization; TACE; sorafenib; Time to untreatable progression; TTUP

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  Patients will be evaluated for these endpoints every 8 weeks

  every 8 week

• Overall Survival

  The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively.

  every 8 week

Secondary Outcomes (9)

• Time To Progression

  every 8 weeks

• Objective Response Rate

  4week after TACE

• Tumor markers

  every 4 weeks

• Safety

  every 4 weeks

• Time To Untreatable Progression(TTUP)

  every 8 week till untreatable progression, assessed up to 100 months

Study Arms (2)

TACE with sorafenib

EXPERIMENTAL

TACE(on demand) with sorafenib till untreatable progression

Drug: TACE with sorafenib

TACE alone

ACTIVE COMPARATOR

TACE(on demand) till unreatable progression

Procedure: TACE alone

Interventions

TACE with sorafenib DRUG

Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.

Also known as: TACE with Nexavar

TACE with sorafenib

TACE alone PROCEDURE

TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.

Also known as: TACE

TACE alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 Years or over
• Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
• Patients who are expected to live more than 12 weeks.
• Patients diagnosed with typical HCC by biopsy,cytology, or diagnostic imaging such as dynamic CT(MRI).Typical HCC is defined by AASLD criteria.
• Patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(RFA) cannot be expected to succeed.
• Patients with tumors which are confirmed to the liver and can be treated by TACE(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
• Patients with viable and measurable target lesion.
• patients with no or one history of TACE therapy.
• patients with an ECOG PS(Performance Status) Score of 0 or 1.
• patients with Child-Pugh class A.
• Patients with laboratory values that meet the following criteria:
• Hemoglobin ≥ 8.5 g/dl
• Granulocytes ≥ 1500/mm3
• Platelet count ≥ 50,000 /mm3
• Total serum bilirubin ≤ 3 mg/dl

You may not qualify if:

• History of malignant tumor, excluding the following cases:
• Curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
• Malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
• Cardiac disease that meet any of the following criteria:
• NYHA Class III or higher congestive heart failure
• History of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
• Arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
• Serious and active infection, except for HBV and HCV
• History of HIV infection
• Renal dialysis
• Diffuse tumor lesion
• Extrahepatic metastasis
• Vascular invasion
• Intracranial tumor
• Preexisting or history of hepatic encephalopathy

Sponsors & Collaborators

• Kindai University: lead

Study Sites (1)

Kinki University Hospital

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Related Publications (2)

• Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Moriguchi M, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Ogasawara S, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y. Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma. Liver Cancer. 2022 Feb 10;11(4):354-367. doi: 10.1159/000522547. eCollection 2022 Jul.

  PMID: 35978604 DERIVED

• Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.

  PMID: 31801872 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Masatoshi Kudo, Professor

  Kindai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: October 2, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

JP (1)