A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer

This study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitone

Trial Details

NCT ID
NCT07101679
Phase
PHASE2
Sponsor
West China Hospital
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • LICSBR
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

  • Inclusion Criteria (1)Histologically confirmed pancreatic ductal adenocarcinoma with diagnosis based on comprehensive assessment of pathology and i…
  • Bone marrow function (no blood transfusion within 14 days prior to screening): White blood cell count (WBC) ≥4.0×10⁹/L, absolute neutrophil count (…
  • Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×UL…
  • Renal function: Serum creatinine (Cr) ≤1.5×ULN, proteinuria ≤2+ or ≤2 g/24h, glomerular filtration rate (GFR) ≥60 mL/min/1.73 m²;

For full eligibility, visit ClinicalTrials.gov.

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