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

Study Overview

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).

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.

Locally Advanced Pancreatic Cancer

RADIATION: Stereotactic body radiation(SBRT)
DRUG: Zimberelimab (GLS-010)

SPARK-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-08-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-08-22
First Submitted that Met QC Criteria 2023-08-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-08-24
First Posted (ACTUAL) 2023-08-24	Results First Posted N/A	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
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.	2 years
Objective response rate (ORR)	Disease control rate will be defined as PR +CR rate.	2 years
Disease Control Rate (DCR)	Disease control rate will be defined as objective response rate + steady disease rate.	2 years
Adverse Events	Based on NCI-CTC AE v5.0	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Junjie Wang, M.D.

Phone Number: +8613701076310

Email: wangjunjie_puth@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Junjie Wang, M.D., Peking University Third Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record