NCT04103398

Brief Summary

The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

September 20, 2019

Last Update Submit

February 25, 2024

Conditions

Hepatocellular CarcinomaSorafenibTransarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

    2 years

Secondary Outcomes (6)

  • Progression Free Survival

    2 years

  • Time To Progression

    2 years

  • Objective Response Rate

    2 years

  • Disease Control Rate

    2 years

  • Adverse Events

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Transarterial chemoembolization combined with sorafenib

EXPERIMENTAL

The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Combination Product: TACE+sorafenib

Transarterial chemoembolization alone

ACTIVE COMPARATOR

Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (oxaliplatin 200mg, raltitrexed 4mg, epirubicin 20mg in cTACE or 70mg in dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Procedure: TACE

Interventions

TACE+sorafenibCOMBINATION_PRODUCT

The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Transarterial chemoembolization combined with sorafenib
TACEPROCEDURE

Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

Transarterial chemoembolization alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years;
  • Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
  • Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion \>3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
  • Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
  • Eastern Cooperative Oncology Group scoring 0-1;
  • Child-Pugh A class;
  • At least 3 months of life expectancy;
  • Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN.

You may not qualify if:

  • Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden\>50%;
  • Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
  • Have contraindications for TACE;
  • Have metastasis in central nervous system;
  • Allergic to intravenous contrast agents;
  • Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
  • Infection of HIV, known syphilis requiring treatment;
  • Have a known history of prior invasive malignancies within 5 years before enrolment;
  • Patients with allotransplantation;
  • Severe dysfunction involving heart, kidney or other organs;
  • Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
  • Patients with mental disorders which may impact informed consent;
  • Unable to orally take drugs;
  • Participating other clinical drug trials 12 months before enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Fan W, Zhu B, Chen S, Wu Y, Zhao X, Qiao L, Huang Z, Tang R, Chen J, Lau WY, Chen M, Li J, Kuang M, Peng Z. Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma: Sorafenib Plus TACE vs TACE Alone Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1047-1054. doi: 10.1001/jamaoncol.2024.1831.

    PMID: 38900435DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ming Kuang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The vice president

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 25, 2019

Study Start

October 2, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)