Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004)

Sponsor
West China Hospital
Study ID
NCT06991491
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GnP in combination with Ivonescimab and SBRT — COMBINATION_PRODUCT
    Gemcitabine 1000mg/m2, ivgtt,vdays 1 and 8, nab-Paclitaxel 125mg/m2, ivgtt, days 1 and 8 in combination with Ivonescimab 20mg/kg d1, every 21 days. Cycle 2 will be synchronized with primary or metastatic SBRT.

Study Details

The aim of this study is to explore the efficacy and safety of a new combination regimen of GnP regimen, SBRT and the anti-PD-1/VEGF bis-antibody, Ivonescimab, in patients with recurrent metastatic advanced pancreatic cancer. The efficacy predictive biomarkers of this combination regimen will be further explored through information such as spatial analysis of the tumor immune microenvironment.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GnP + Ivonescimab +SBRT
    Only one cohort of patients will be included, specifically those with pathologically confirmed metastatic pancreatic cancer and, who have not received any prior systemic anti-tumor therapy (including chemotherapy, radiation, or other investigational treatments) or those who have had prior radical pancreatic surgery for pancreatic cancer and have received regular postoperative adjuvant chemotherapy and have developed recurrence or metastasis more than 6 months after the last adjuvant chemotherapy.

Primary Outcome Measure

6-month-PFS rate [ Time Frame: Follow up with patients for up to 24 months ]

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