Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 3

Conditions: Liver Cancer

Treatments: Procedure: transarterial chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02038296

TAE001

Details and patient eligibility

About

To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

Enrollment: 162 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
• HCC with no previous treatment;
• age between 18 and 75 years;
• Life expectancy of at least 8 weeks;
• main tumor size greater than 5 cm;
• adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
• adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
• Child-Pugh classification A or B grade;
• Barcelona Clinic Liver Cancer (BCLC) stage B or C;
• Eastern Co-operative Group performance status of zero or one.

Exclusion criteria

• a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
• diffuse-type HCC;
• evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
• severe underlying cardiac or renal diseases;
• color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

162 participants in 3 patient groups

Group 1

Experimental group

Description:

Group 1 received single-drug (doxorubicin)transarterial chemoembolization.

Treatment:

Procedure: transarterial chemoembolization

Group 2

Experimental group

Description:

Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization

Treatment:

Procedure: transarterial chemoembolization

Group 3

Experimental group

Description:

Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Treatment:

Procedure: transarterial chemoembolization