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Adjuvant Therapies for Patients With HCC and MVI

NCT02436902 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-01-10

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

TACE

TACE is performed one month after resection.

DRUG

Sorafenib

Sorafenib is submitted one month after resection.

DRUG

TACE plus sorafenib

TACE plus sorafenib will be submitted one month after resection.

OTHER

empty control

This group will not receive adjuvant therapy.

Sponsors & Collaborators

  • Guangxi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-08-23
Completion
2022-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436902 on ClinicalTrials.gov