Status:
NOT_YET_RECRUITING
SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
Lead Sponsor:
Peking University Third Hospital
Conditions:
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
Detailed Description
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 endpo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06009029
Start Date
August 1 2023
End Date
July 1 2027
Last Update
August 24 2023
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