A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

Sponsor
West China Hospital
Study ID
NCT07336953
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • GnP — DRUG
    The GnP regimen is a standard-of-care chemotherapy consisting of Gemcitabine and nab-Paclitaxel administered in 21-day cycles.
  • SBRT — RADIATION
    Stereotactic Body Radiotherapy (SBRT) is utilized in the experimental arm as a high-dose local treatment intended to induce immunogenic cell death and synergize with immunotherapy.
  • Serplulimab — DRUG
    Serplulimab is an immunotherapy component used in the experimental arm of this study to enhance the anti-tumor immune response.

Study Details

This Phase III randomized trial, evaluates whether adding targeted radiation (SBRT) and an immunotherapy drug (Serplulimab) to standard chemotherapy (GnP) can extend the lives of patients with advanced pancreatic cancer.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GnP+Serplulimab+SBRT
  • Active Comparator: GnP

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of randomization until the date of death from any cause, assessed up to approximately 30 months. ]

Central Contacts

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