Adjuvant Therapies for Patients With HCC and MVI

Last updated: January 7, 2020
Sponsor: Guangxi Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Liver Cancer

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02436902
A-TACE/S-HCC
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-75 years

  • Diagnosis of HCC was confirmed by histopathological examination of surgical samples inall patients

  • Patients with microvascular invasion by histopathological examination of surgicalsamples

  • 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 distantmetastases 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

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 withthe 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 andhis/her compliance in the study

  • Pregnant or breast-feeding patients

Study Design

Total Participants: 240
Study Start date:
February 01, 2019
Estimated Completion Date:
August 30, 2022

Connect with a study center

  • Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

    Nanning, Guangxi 530021
    China

    Active - Recruiting

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