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

Primary Purpose

Locally Advanced Pancreatic Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Stereotactic body radiation(SBRT)
Zimberelimab (GLS-010)
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer focused on measuring Locally Advanced Pancreatic Cancer, SBRT, Zimberelimab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SBRT Combined With Zimberelimab

    Arm Description

    Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab

    Outcomes

    Primary Outcome Measures

    Overall survival (OS)
    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)
    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)
    Disease control rate will be defined as PR +CR rate.
    Disease Control Rate (DCR)
    Disease control rate will be defined as objective response rate + steady disease rate.
    Adverse Events
    Based on NCI-CTC AE v5.0

    Full Information

    First Posted
    August 9, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06009029
    Brief Title
    SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    July 2026 (Anticipated)
    Study Completion Date
    July 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Locally Advanced Pancreatic Cancer
    Keywords
    Locally Advanced Pancreatic Cancer, SBRT, Zimberelimab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SBRT Combined With Zimberelimab
    Arm Type
    Experimental
    Arm Description
    Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic body radiation(SBRT)
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Zimberelimab (GLS-010)
    Other Intervention Name(s)
    Immunotherapy
    Intervention Description
    Zimberelimab (GLS-010),240mg d1 iv Q21D
    Primary Outcome Measure Information:
    Title
    Overall survival (OS)
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Description
    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.
    Time Frame
    2 years
    Title
    Objective response rate (ORR)
    Description
    Disease control rate will be defined as PR +CR rate.
    Time Frame
    2 years
    Title
    Disease Control Rate (DCR)
    Description
    Disease control rate will be defined as objective response rate + steady disease rate.
    Time Frame
    2 years
    Title
    Adverse Events
    Description
    Based on NCI-CTC AE v5.0
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junjie Wang, M.D.
    Phone
    +8613701076310
    Email
    wangjunjie_puth@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Junjie Wang, M.D.
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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