Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer

NCT ID: NCT06781086

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2028-12-31

Brief Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study 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.

Detailed Description

This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study 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. About 156 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus AG) and control group (placebo plus AG) at a ratio of 1:1. The main endpoint is disease-free survival (DFS). Additional end points include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), postoperative complications and safety, etc.

Conditions

Pancreatic Cancer, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nimotuzumab+ AG

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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+ AG

Group Type: PLACEBO_COMPARATOR

AG regimen

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Eligibility Criteria

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 the NCCN criteria). If it is resectable pancreatic cancer, any of the following high-risk factors should also be met: 1) Carbohydrate Antigen 19-9(CA199) > 500 U/ml; 2) the maximum diameter of the primary tumor > 3.0 cm; 3) severe weight loss; 4) Extreme pain; regional lymph node metastasis (N1 or N2);
• 4. Voluntarily accept sample collection (for KRAS gene testing and subsequent 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 of 0 or 2;
• 7. Life expectancy of at least 3 months;
• 8. Women of childbearing age should have a negative result of serum human chorionic gonadotropin (HCG) test or urine pregnancy test 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 (Systolic Blood Pressure>160mmHg or Diastolic Blood Pressure>100mmHg); compensatory heart failure (New York Heart Association (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. bleeding or clotting disorder;
• 6. Known allergy to prescription or any component of the prescription used in this study;
• 7. With human immunodeficiency virus (HIV) or syphilis infection, or active hepatitis (hepatitis B, hepatitis 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

IST-Nim-PC-3

Identifier Type: -

Identifier Source: org_study_id