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

SPARK-1

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

2023-08-01

2026-07-01

2027-07-01

Not yet recruiting

Early phase I

96

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2023-08-24