NCT06512896

Clinical Study on Intraluminal Injection of FOLactis

Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Intraluminal Injection of FOLactis in Patients With Advanced Solid Tumors Accompanied by Malignant Pleural and Peritoneal Effusion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.

Conditions

• Solid Tumor
• Immune Response
• Pleural Effusion, Malignant
• Peritoneal Effusion

Interventions

Type	Name	Description
OTHER	FOLactis	Evaluate the safety,tolerability, efficacy of intraluminal injection of FOLactis combined with chemotherapy, target therapy, and immunotherapy

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-03-30
• Completion: 2026-05-30
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: China