The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 2
Started
2025-12-10
Last updated
2025-12-11
Condition(s) studied
Pancreatic Cancer, Adult
Investigational drug(s) / intervention(s)
NimotuzumabAG regimenPlacebo
Nimotuzumab: Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).
AG regimen: Patients will receive 3 cycles of AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle).
Placebo: Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ;
* 9\. Good compliance and signed informed consent.
Exclusion Criteria:
* 1\. Previous treatment for pancreatic cancer.
* 2\. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness;
* 3\. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases;
* 4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* 5\. Presence of bleeding or coagulation disorders;
* 6\. Known allergy to prescription or any component of the prescription used in this study;
* 7\. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C);
* 8\. Women who are pregnant or are breastfeeding;
* 9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Primary outcome measure(s)
disease-free survival (DFS) — Up to 24 months The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Trial sites (2)
Facility
City
Region
Status
Kuirong Jiang
Nanjing
Jiangsu
Chunyi Hao
Beijing
China
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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