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

Locally Advanced Pancreatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06009029
• Other study ID #: SPARK-1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2023
• Est. completion date: July 2027

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: Junjie Wang, M.D.
• Phone: +8613701076310
• Email: wangjunjie_puth[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

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