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.
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);
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);
Parallel
Nimotuzumab
DrugPatients 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
DrugPatients 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
DrugPatients 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).
disease-free survival (DFS)
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
overall survival (OS)
The time from the date of randomization to death due to any cause.
R0 resection rate
Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Surgical Resection rate
Patients who undergo surgical resection will be documented.
Objective response rate (ORR)
Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
