NCT06194695

DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma

Combination of Transcatheter Arterial Chemoembolization With Drug-eluting Beads, Lenvatinib and Anti-PD(L)1 Antibody for Downstaging Intrahepatic Cholangiocarcinoma for Radical Surgical Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Ze-yang Ding, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of Drug-eluting Beads-transarterial chemoembolization (DEB-TACE), lenvatinib, and anti-PD-1/ PD-L1 antibody for patients with advanced intrahepatic cholangiocarcinoma who were initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Detailed description

The multicenter, non-random, open and prospective real-world cohort study is conducted at 4 research centers, including 3 centers (Hankou, Sino-French New District, and Optical Valley) of Tongji hospital (Wuhan, China) and one in the second affiliated hospital of Fujian Medical University (Quanzhou, China). It is estimated that 100 patients with advanced intrahepatic cholangiocarcinoma will be enrolled in these 4 research centers. And it is planned to complete the enrollment within 2 year and it is expected that all enrolled subjects will reach the observation end point in 3 years. Radiological assessments are performed every two cycles over the course of treatment, then every 3 months within the first two years following the completion of treatment and every 6 months thereafter, until PD were recorded. All subjects are followed until death or lost to follow up.

Conditions

• Cholangiocarcinoma Non-resectable

Interventions

Type	Name	Description
PROCEDURE	drug eluting beads-transcatheter arterial chemoembolization	transcatheter arterial chemoembolization with doxorubicin embedded eluting beads- was performed every 3 weeks through the tumor feeding arteries.
DRUG	envatinib plus anti-PD(L)1	oral use of lenvatinib plus intravenous injection of anti-PD(L)1 antibodies. Anti-PD-L1 antibodies includes duravalumab, atezolizumab, or envolizumab, and anti-PD1 antibodies include pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab, or toripalimab.

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2024-01-08
• Last updated: 2024-01-09

Locations

1 site across 1 country: China