SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Aug 22, 2023

Keywords

ClinConnect Summary

The SPARK-1 study is a clinical trial designed to explore a new treatment approach for patients with locally advanced pancreatic cancer. This trial will test the combination of a type of radiotherapy called Stereotactic Body Radiation Therapy (SBRT) with a medication known as Zimberelimab (GLS-010). The goal is to determine how effective and safe this combination is for patients whose cancer cannot be surgically removed.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of locally advanced pancreatic cancer that has been deemed unresectable, meaning it cannot be removed with surgery. They should also have a good performance status, indicating they can carry out daily activities with minimal difficulty. Participants will be monitored throughout the trial to assess their response to the treatment and any side effects. It’s important to note that the trial is not yet recruiting patients, so those interested will need to wait for it to begin. If you or a loved one meets the eligibility criteria and is considering participation, it could provide an opportunity to access a potentially new treatment option.

Gender

ALL

Eligibility criteria

• 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.