Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk … (NCT07277452) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
China156 participantsStarted 2025-12-10
Plain-language summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age 18-75 years old, gender unlimited;
* 2\. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
* 3\. Confirmed as resectable/borderline resectable pancreatic cancer by CT/MRI imaging (resectability assessment refers to NCCN guidelines). For resectable pancreatic cancer, at least one of the following high-risk factors must be met: 1) CA199 \> 500 U/ml; 2) the maximum diameter of the primary tumor \> 3.0 cm; 3) Severe weight loss (BMI \< 18.5 kg/m² OR involuntary weight loss \> 15% within 6 months); 4) Severe pain (Numeric Rating Scale \[NRS\]≥ 4); 5) Definite regional lymph node metastasis (N1 or N2) OR suspicious regional lymph node metastasis (short-axis diameter of lymph nodes ≥15 mm);
* 4\. Voluntarily agree to sample collection (for KRAS gene testing and post-hoc analysis);
* 5\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
* 6\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
* 7\. Life expectancy of at least 3 months;
* 8\. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopau…
What they're measuring
1
disease-free survival (DFS)
Timeframe: Up to 24 months
Trial details
NCT IDNCT07277452
SponsorThe First Affiliated Hospital with Nanjing Medical University