SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SBRT Combined With Zimberelimab Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab |
Radiation: Stereotactic body radiation(SBRT)
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.
Drug: Zimberelimab (GLS-010)
Zimberelimab (GLS-010),240mg d1 iv Q21D
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-75 years old.
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Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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The expected survival ≥ 3 months.
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At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
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Patient must have adequate organ function defined by the study-specified laboratory tests.
Exclusion Criteria:
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Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
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Woman who are pregnant or breastfeeding.
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Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
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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.
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Contraindications to immunotherapy.
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Other conditions that investigator decides not suitable for the trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Third Hospital
Investigators
- Principal Investigator: Junjie Wang, M.D., Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPARK-1