NCT05303844

Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites

A Phase 1b Dose-escalation and Cohort-expansion Study of the Safety/Tolerability, and Efficacy of Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites (OPTIONS-02)

• Status: Unknown
• Phase: Phase 1
• 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 safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab for patients with refractory malignant ascites.

Detailed description

This study is to evaluate the safety, effectiveness of local immune activation, and efficiency in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101 and Tislelizumab.

Conditions

• Refractory Malignant Ascites

Interventions

Type	Name	Description
DRUG	H101	H101 intratumorally injection starts at day 0.
DRUG	Tislelizumab	Tislelizumab will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Timeline

• Start date: 2022-04-02
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2022-03-31
• Last updated: 2023-04-12

Locations

1 site across 1 country: China