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

Phase 2

Not yet recruiting

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Radiation: Stereotactic body radiation(SBRT); Drug: Zimberelimab (GLS-010)

• Registration Number: NCT06009029
• Lead Sponsor: Peking University Third Hospital

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 endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT Combined With Zimberelimab	Zimberelimab (GLS-010)	Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
SBRT Combined With Zimberelimab	Stereotactic body radiation(SBRT)	Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 years	Disease control rate will be defined as PR +CR rate.
Disease Control Rate (DCR)	2 years	Disease control rate will be defined as objective response rate + steady disease rate.
Adverse Events	2 years	Based on NCI-CTC AE v5.0
Progression-free survival (PFS)	2 years	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.