This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
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.
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.
Single group
Stereotactic body radiation(SBRT)
RadiationSBRT: 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.
Zimberelimab (GLS-010)
DrugZimberelimab (GLS-010),240mg d1 iv Q21D
Overall survival (OS)
Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.
Progression-free survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Objective response rate (ORR)
Disease control rate will be defined as PR +CR rate.
Disease Control Rate (DCR)
Disease control rate will be defined as objective response rate + steady disease rate.
Adverse Events
Based on NCI-CTC AE v5.0
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