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

Trial ID: NCT06009029

Interventional - Phase 2 - Not yet recruiting

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

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

• Stereotactic body radiation(SBRT)
• Zimberelimab (GLS-010)

Eligibility

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.

Sponsor

Peking University Third Hospital

Source: Clinicaltrials.gov

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