A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as F⌠(NCT07336953) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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)
198 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range18 Years â 75 Years
SexALL
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Inclusion criteria
â. Patients with pathologically confirmed metastatic pancreatic cancer who are inoperable, with diagnosis based on a comprehensive assessment of pathology and imaging studies (CT or MRI);
â. Patients who have not previously received any systemic anticancer therapy (including chemotherapy, radiotherapy, or other investigational treatments), or who underwent radical pancreatic cancer resection with standard neoadjuvant or adjuvant chemotherapy and experienced recurrence or progression more than 6 months after the last adjuvant chemotherapy;
â. Age 18-75 years, no gender restriction;
â. ECOG performance status 0-2;
â. At least one measurable tumor lesion: âĽ10 mm in longest diameter on spiral CT, âĽ15 mm in shortest diameter for lymph nodes; âĽ20 mm in maximum diameter on conventional CT or physical examination;
â. No more than 10 metastatic lesions throughout the body excluding the primary tumor, with the largest metastatic lesion â¤10 cm in diameter; and at least one lesion deemed suitable for radiotherapy based on imaging assessment;
â. Normal major organ function (bone marrow, hepatic, renal, coagulation, etc.):
â. Expected survival âĽ3 months;
Exclusion criteria
â. Known allergy to any investigational drug;
â. Subjects with known or suspected central nervous system (CNS) metastases, i.e., those exhibiting signs or symptoms suggestive of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;
What they're measuring
1
Overall Survival (OS)
Timeframe: From the date of randomization until the date of death from any cause, assessed up to approximately 30 months.
â. History of other malignancies within 5 years prior to first administration of the study drug (excluding adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ);
â. Prior treatment with any immune checkpoint inhibitor (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);
â. Requirement for concomitant antitumor therapy outside the study regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, other immunotherapy regimens, radiotherapy, or antitumor Chinese herbal medicine;
â. Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 7 days prior to the first study dose;
â. Subjects requiring systemic treatment with corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days prior to the first study drug administration; inhaled or topical steroids are permitted in the absence of active autoimmune disease, and adrenal corticosteroid replacement therapy at a dose â¤10 mg/day prednisone equivalent is allowed;
â. Recipients of antitumor vaccines or live vaccines within 4 weeks prior to the first study drug administration;