TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE-HAIC; Procedure: TACE; Drug: Targeted therapy; Drug: PD-1 inhibitors

• Registration Number: NCT05535998
• Lead Sponsor: Yunfei Yuan

Brief Summary

Hepatocellular carcinoma (HCC) is characterized with vascular invasion, particularly of the portal vein, resulting in portal vein tumor thrombus (PVTT) in 10%-40% of HCC patients at the time of HCC diagnosis. The prognosis of these patients is extremely poor.Treatment efficacy and safety using a combined therapy (TACE-HAIC combined with TKIs and PD-1 inhibitors) were compared with TACE alone in treatment of HCC patients with PVTT.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

• (a) HCC patients with PVTT (Vp1-4) treated by TACE, or the combination therapy (TACE-HAIC combined with TKIs or an PD-1 inhibitors) as initial treatment; (b) age between 18 and 75 years; (c) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L); (f) no extrahepatic metastasis.

Exclusion Criteria

• (a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) incomplete medical data; (d) loss to follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)	TACE-HAIC	Patients recieve combined with TKIs and PD-1 inhibitors
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)	Targeted therapy	Patients recieve combined with TKIs and PD-1 inhibitors
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)	PD-1 inhibitors	Patients recieve combined with TKIs and PD-1 inhibitors
TACE alone group	TACE	TACE alone

Primary Outcome Measures

Name	Time	Method
Tumor Response	24 months	The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
Overall survival	24 months	Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Progression-free survival	24 months	Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.

Secondary Outcome Measures

Name	Time	Method
Conversion rate	24 rates	Rate of patients underwent hepatic surgery after careful evaluation when an estimated residual liver volume \>30-40% could be remained after R0 surgery by 2 experienced surgeons

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 GuangZhou, Guangdong, China