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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Locally Advanced Pancreatic Cancer

Intervention / Treatment
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* Radiation: Stereotactic body radiation(SBRT)
* Drug: Zimberelimab (GLS-010)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT Combined With Zimberelimab<br>Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab | Radiation: Stereotactic body radiation(SBRT)<br>* SBRT: 7-10 Gy/F, 5 doses Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.<br>Drug: Zimberelimab (GLS-010)<br>* Zimberelimab (GLS-010),240mg d1 iv Q21D<br>* Other names: Immunotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment. | 2 years | 
| Objective response rate (ORR) | Disease control rate will be defined as PR +CR rate. | 2 years | 
| Disease Control Rate (DCR) | Disease control rate will be defined as objective response rate + steady disease rate. | 2 years | 
| Adverse Events | Based on NCI-CTC AE v5.0 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Advanced Pancreatic Cancer, SBRT, Zimberelimab