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Adjuvant Therapies for Patients With HCC and MVI (A-TACE/S-HCC)

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ClinicalTrials.gov Identifier: NCT02436902
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-Hong Zhong, Guangxi Medical University

Brief Summary:

Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.

Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: TACE Drug: Sorafenib Drug: TACE plus sorafenib Procedure: transarterial chemotherapy plus embolization Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TACE
Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.
Procedure: TACE
Other Name: transarterial chemoembolization

Procedure: transarterial chemotherapy plus embolization
Active Comparator: sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
Drug: Sorafenib
TACE plus sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. At the same time, TACE is performed two to four weeks after hepatic resection.
Drug: TACE plus sorafenib
Procedure: transarterial chemotherapy plus embolization
No Intervention: empty control
This group patients will receive best supportive care.



Primary Outcome Measures :
  1. Overall survivals [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: 30-day ]
  2. Recurrence rates [ Time Frame: 1 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
  • Patients with microvascular invasion by histopathological examination of surgical samples
  • Patients have Child-Pugh A or B liver function
  • No previous neoadjuvant treatment
  • No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
  • No malignancy other than HCC for 5 years prior to the initial HCC treatment

Exclusion Criteria:

  • History of cardiac disease
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436902


Locations
China, Guangxi
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University Recruiting
Nanning, Guangxi, China, 530021
Contact: Bang-De Xiang, MD,PhD    86-771-5330855    xiangbangde@163.com   
Sponsors and Collaborators
Guangxi Medical University

Publications:
Responsible Party: Jian-Hong Zhong, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02436902     History of Changes
Other Study ID Numbers: A-TACE/S-HCC
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Chlorotrianisene
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal