NCT07336953
Not yet recruiting
Phase 3
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)
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- West China Hospital
- Enrollment
- 198
- Primary Endpoint
- Overall Survival (OS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.):
- •Bone marrow function (no transfusion within 14 days prior to screening): WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥80×10⁹/L, Hb ≥90g/L;
- •Liver function: ALT and AST ≤3× upper limit of normal (ULN), TBIL ≤1.5×ULN (if liver metastases present, ALT and AST ≤5×ULN, TBIL ≤2×ULN acceptable for liver-metastatic subjects); Child-Pugh score ≤7 points;
- •Renal function: Serum Cr ≤1.5 ULN, proteinuria ≤2+ or ≤2 g/24h, estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using Cockcroft-Gault formula);
Exclusion Criteria
- •Known allergy to any investigational drug;
- •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;
- •Major surgery within 28 days prior to the first study drug administration, defined as surgery requiring at least 3 weeks of postoperative recovery before study treatment initiation. Tumor needle biopsies or lymph node excision biopsies are permitted;
- •Requirement for concomitant medications during the trial that may affect the metabolism of the study drug;
Arms & Interventions
GnP+Serplulimab+SBRT
Experimental
Intervention: GnP (Drug)
GnP+Serplulimab+SBRT
Experimental
Intervention: SBRT (Radiation)
GnP+Serplulimab+SBRT
Experimental
Intervention: Serplulimab (Drug)
GnP
Active Comparator
Intervention: GnP (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From the date of randomization until the date of death from any cause, assessed up to approximately 30 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dan Cao
Professor and Chief Physician, West China Hospital, Sichuan University
West China Hospital
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