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NCT Number: NCT06009029

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

This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).

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Key information

Conditions

Locally Advanced Pancreatic Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic body radiation(SBRT)

Radiation

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.

Zimberelimab (GLS-010)

Drug

Zimberelimab (GLS-010),240mg d1 iv Q21D

Other names: Immunotherapy

Primary outcomes

  1. Overall survival (OS)

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 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.

  2. Objective response rate (ORR)

    Time frame: 2 years

    Disease control rate will be defined as PR +CR rate.

  3. Disease Control Rate (DCR)

    Time frame: 2 years

    Disease control rate will be defined as objective response rate + steady disease rate.

  4. Adverse Events

    Time frame: 2 years

    Based on NCI-CTC AE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Junjie Wang, M.D.

CONTACT

[email protected]

+8613701076310

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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