TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

NCT ID: NCT04103398

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2023-12-31

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.

Detailed Description

The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.

Conditions

Hepatocellular Carcinoma; Sorafenib; Transarterial Chemoembolization

Study Design

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

Study Groups

Transarterial chemoembolization combined with sorafenib

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.

Group Type: EXPERIMENTAL

TACE+sorafenib

Intervention Type: COMBINATION_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 alone

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.

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

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.

Interventions

TACE+sorafenib

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.

Intervention Type: COMBINATION_PRODUCT

TACE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age: 18-75 years;

2. Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;

3. 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;

4. Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;

5. Eastern Cooperative Oncology Group scoring 0-1;

6. Child-Pugh A class;

7. At least 3 months of life expectancy;

8. 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.

Exclusion Criteria

1. Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden>50%;

2. Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;

3. Have contraindications for TACE;

4. Have metastasis in central nervous system;

5. Allergic to intravenous contrast agents;

6. Pregnant or breastfeeding women, or expecting to conceive or father children within two years;

7. Infection of HIV, known syphilis requiring treatment;

8. Have a known history of prior invasive malignancies within 5 years before enrolment;

9. Patients with allotransplantation;

10. Severe dysfunction involving heart, kidney or other organs;

11. Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;

12. Patients with mental disorders which may impact informed consent;

13. Unable to orally take drugs;

14. Participating other clinical drug trials 12 months before enrolment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

The vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38900435 (View on PubMed)

Other Identifiers

20190921

Identifier Type: -

Identifier Source: org_study_id