NCT05823987

Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS-05)

A Phase II Study of Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of oncolytic virotherapy combined with Tislelizumab plus lenvatinib in patients with advanced biliary tract cancer (BTC).

Detailed description

Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many type of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of oncolytic virotherapy combined with Tislelizumab plus lenvatinib in patients with advanced BTC.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	H101	a modified human recombinant type 5 adenovirus with genetic modifications
DRUG	Tislelizumab	a PD-1 immune check inhibitor
DRUG	Lenvatinib	Lenvatinib capsules

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-04-21
• Last updated: 2023-06-27

Locations

1 site across 1 country: China