NCT07336953

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)

A Randomized, Controlled, Phase III Study of Gemcitabine and Nab-paclitaxel (GnP) Combined With Stereotactic Body Radiation Therapy (SBRT) and Serplulimab Versus GnP as First-Line Therapy in Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2026-01-13
• Last updated: 2026-01-13