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)

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

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.

Inclusion Criteria:

• 18-75 years old.
• Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• The expected survival ≥ 3 months.
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
• Patient must have adequate organ function defined by the study-specified laboratory tests.

Exclusion Criteria:

• Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
• Woman who are pregnant or breastfeeding.
• Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
• Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
• Contraindications to immunotherapy.
• Other conditions that investigator decides not suitable for the trial.