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)
NCT07336953 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2026-01-13
Summary
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.
Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
Interventions
- DRUG
-
GnP
The GnP regimen is a standard-of-care chemotherapy consisting of Gemcitabine and nab-Paclitaxel administered in 21-day cycles.
- RADIATION
-
SBRT
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.
- DRUG
-
Serplulimab
Serplulimab is an immunotherapy component used in the experimental arm of this study to enhance the anti-tumor immune response.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2027-07-31
- Completion
- 2028-07-31
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