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

NCT ID: NCT06009029

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2027-07-31

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.

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT Combined With Zimberelimab

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

Group Type: EXPERIMENTAL

Stereotactic body radiation(SBRT)

Intervention Type: 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)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: RADIATION

Zimberelimab (GLS-010)

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

Intervention Type: DRUG

Other Intervention Names

Immunotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junjie Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

Junjie Wang, M.D.

Role: CONTACT

wangjunjie_puth@163.com

+8613701076310

Other Identifiers

SPARK-1

Identifier Type: -

Identifier Source: org_study_id