NCT06301828

Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors

A Prospective, Single-arm Clinical Study of Endostar Combined With Stereotactic Body Radiation Therapy and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors After Multi-line Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

Detailed description

This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DRUG	Envafolimab Injection	Endostar+SBRT+Envafolimab Injection
DRUG	Endostar	Endostar+SBRT+Envafolimab Injection

Timeline

• Start date: 2024-02-21
• Primary completion: 2025-06-21
• Completion: 2026-02-21
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: China