NCT04220944

Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

Microwave Ablation Combined With Simultaneous TACE Plus Sintilimab for Unresectable HCC.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.

Detailed description

Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death. Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication. Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib. Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.

Conditions

• Hepatic Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks.
PROCEDURE	Microwave Ablation	The ablation area should covered at least two thirds the size of the nodules.
PROCEDURE	TACE	Patient was treated with epirubicin lipiodol emulsion(Epirubicin 40mg, Lipiodol 10ml).Embolic materials such as gelfoam or microsphere was aslo administered until complete stasis in segmental or subsegmental arterial branches.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-10-30
• Completion: 2024-12-30
• First posted: 2020-01-07
• Last updated: 2024-08-01

Locations

1 site across 1 country: China