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Not yet recruiting NCT06009029

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

Phase II Interventional Locally Advanced Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic body radiation(SBRT), Zimberelimab (GLS-010).
Who it may be relevant to
Registry conditions: Locally Advanced Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Overall survival (OS) [Time frame: 2 years]
Secondary outcome measures (4)
  • Progression-free survival (PFS) [Time frame: 2 years]
  • Objective response rate (ORR) [Time frame: 2 years]
  • Disease Control Rate (DCR) [Time frame: 2 years]
  • Adverse Events [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06009029 · SPARK-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗