NCT06009029

SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)

A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).

Detailed description

This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiation(SBRT)	SBRT: 7-10 Gy/F, 5 doses Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.
DRUG	Zimberelimab (GLS-010)	Zimberelimab (GLS-010),240mg d1 iv Q21D

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2023-08-24
• Last updated: 2023-08-24