Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (NOTABLE-309)

Biotech Pharmaceutical

Status and phase

Withdrawn

Phase 2

Conditions

Pancreatic Cancer, Adult

Treatments

Drug: Placebo

Drug: Nimotuzumab

Drug: AG regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT06781086

IST-Nim-PC-3

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.