Menu
Not yet recruiting NCT07277452

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

Phase II Interventional Pancreatic Cancer, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nimotuzumab, AG regimen, Placebo.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer

Overview

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.

Detailed description

This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled trial, led by two leading centers: The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute. Its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG regimen) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer. Approximately 156 patients will be enrolled in this study and randomly assigned in a 1:1 ratio to the experimental group (Nimotuzumab plus AG regimen) and the control group (placebo plus AG regimen). The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), incidence of postoperative complications, and safety, etc.

Interventions

  • Drug 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).
  • 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).
  • 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).

Primary outcome measures

  • disease-free survival (DFS) [Time frame: Up to 24 months]
Secondary outcome measures (5)
  • overall survival (OS) [Time frame: Up to 24 months]
  • R0 resection rate [Time frame: within 30 days after surgery]
  • Surgical Resection rate [Time frame: within 30 days after surgery]
  • Objective response rate (ORR) [Time frame: Up to 9 weeks during the neoadjuvant treatment]
  • adverse events [Time frame: Up to 30 days after last administration]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Kuirong Jiang — Nanjing
  • Chunyi Hao — Beijing

Identifiers

NCT: NCT07277452 · IST-Nim-PC-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗