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

NCT06009029 | Not Yet Recruiting Phase 2

• 1 other identifier: SPARK-1
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Locally Advanced Pancreatic Cancer; SBRT; Zimberelimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  2 years

• Objective response rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Adverse Events

  2 years

Study Arms (1)

SBRT Combined With Zimberelimab

EXPERIMENTAL

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

Radiation: Stereotactic body radiation(SBRT); Drug: Zimberelimab (GLS-010)

Interventions

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.

SBRT Combined With Zimberelimab

Zimberelimab (GLS-010) DRUG

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

Also known as: Immunotherapy

SBRT Combined With Zimberelimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Interventions

Radiosurgery; zimberelimab; Immunotherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Immunomodulation; Biological Therapy

Study Officials

• Junjie Wang, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junjie Wang, M.D.

CONTACT

+8613701076310; wangjunjie_puth@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 24, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share