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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. 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;
. Age 18-75 years, no gender restriction;
. ECOG performance status 0-2;
. At least one measurable tumor lesion: ≥10 mm in longest diameter on spiral CT, ≥15 mm in shortest diameter for lymph nodes; ≥20 mm in maximum diameter on conventional CT or physical examination;
. No more than 10 metastatic lesions throughout the body excluding the primary tumor, with the largest metastatic lesion ≤10 cm in diameter; and at least one lesion deemed suitable for radiotherapy based on imaging assessment;
. Normal major organ function (bone marrow, hepatic, renal, coagulation, etc.):
. Expected survival ≥3 months;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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;
. 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);
. Prior treatment with any immune checkpoint inhibitor (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);
. 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;
. Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 7 days prior to the first study dose;
. 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 ≤10 mg/day prednisone equivalent is allowed;
. Recipients of antitumor vaccines or live vaccines within 4 weeks prior to the first study drug administration;