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Trial Title:
SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
NCT ID:
NCT06009029
Condition:
Locally Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Immunomodulating Agents
Conditions: Keywords:
Locally Advanced Pancreatic Cancer
SBRT
Zimberelimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiation(SBRT)
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.
Arm group label:
SBRT Combined With Zimberelimab
Intervention type:
Drug
Intervention name:
Zimberelimab (GLS-010)
Description:
Zimberelimab (GLS-010),240mg d1 iv Q21D
Arm group label:
SBRT Combined With Zimberelimab
Other name:
Immunotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009029
