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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)