Adjuvant Therapies for Patients With HCC and MVI

NCT ID: NCT02436902

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-08-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE

Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

TACE is performed one month after resection.

empty control

Intervention Type: OTHER

This group will not receive adjuvant therapy.

sorafenib

Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Sorafenib is submitted one month after resection.

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.

Group Type: OTHER

TACE plus sorafenib

Intervention Type: DRUG

TACE plus sorafenib will be submitted one month after resection.

empty control

Intervention Type: OTHER

This group will not receive adjuvant therapy.

empty control

This group patients will receive best supportive care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TACE

TACE is performed one month after resection.

Intervention Type: PROCEDURE

Sorafenib

Sorafenib is submitted one month after resection.

Intervention Type: DRUG

TACE plus sorafenib

TACE plus sorafenib will be submitted one month after resection.

Intervention Type: DRUG

empty control

This group will not receive adjuvant therapy.

Intervention Type: OTHER

Other Intervention Names

transarterial chemoembolization

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Hong Zhong

Guangxi Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bang-De Xiang, MD,PhD

Role: primary

xiangbangde@163.com

86-771-5330855

References

Zhong JH, Li LQ. Postoperative adjuvant transarterial chemoembolization for participants with hepatocellular carcinoma: A meta-analysis. Hepatol Res. 2010 Oct;40(10):943-53. doi: 10.1111/j.1872-034X.2010.00710.x.

Reference Type: BACKGROUND

PMID: 20887328 (View on PubMed)

Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

Reference Type: BACKGROUND

PMID: 18650514 (View on PubMed)

Zhou L, Rui JA, Wang SB, Chen SG, Qu Q. Early recurrence in large hepatocellular carcinoma after curative hepatic resection: prognostic significance and risk factors. Hepatogastroenterology. 2014 Oct;61(135):2035-41.

Reference Type: BACKGROUND

PMID: 25713907 (View on PubMed)

Other Identifiers

A-TACE/S-HCC

Identifier Type: -

Identifier Source: org_study_id