Clinical trial · Interventional
SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)
NCT06009029CI-TRIAL-00069047not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiation(SBRT) | Radiation | — | UNRESOLVED |
| Zimberelimab (GLS-010) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT Combined With Zimberelimab
- description
- Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
- interventionNames
- Radiation: Stereotactic body radiation(SBRT)
- Drug: Zimberelimab (GLS-010)
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
- 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 outcomes (4)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.