Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of effectiveness and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

• Written informed consent obtained.

• Age ≥ 18 years at time of study entry.

• Cytologically diagnosed solid tumor malignancy.

• Malignant peritoneal ascites confirmed by peritoneal brush cytology.

• Failures from chemotherapy against malignant ascites.

• Cooperative Oncology Group-Status (ECOG Status) 0 or 1

Exclusion Criteria:

• History or evidence of active autoimmune disease that requires systemic treatment.

• Acute or chronic active Hepatitis B or C infection or HIV infection.

• Previous (<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.

• Concurrent severe illness such as active infection.