Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer

Официальное название

Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study

Обзор

This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.

Подробное описание

This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

Вмешательства

• Препарат Nimotuzumab
  Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.
• Препарат AG
  Patients will receive nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1,000 mg/m\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

Первичные конечные точки

• disease-free survival (DFS) [Срок оценки: Up to 24 months]

Вторичные конечные точки (4)

• distant metastasis-free survival (DMFS) [Срок оценки: Up to 24 months]
• overall survival (OS) [Срок оценки: Up to 24 months]
• tumor-related markers [Срок оценки: Up to 24 months]
• adverse events [Срок оценки: Up to 30 days after last administration]

Критерии участия

Критерии включения

• 1\. Able and willing to provide a written informed consent.
• 2\. Age 18-75 years old, gender unlimited;
• 3\. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
• 4\. Postoperative pathology suggested R0/R1 resection;
• 5\. EGFR positive (by immunohistochemistry);
• 6\. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
• 7\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^9/L; hemoglobin≥9.0 g/dL; 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;
• 8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• 9\. Postoperative survival is expected to be ≥3 months;
• 10\. Fertile subjects are willing to take contraceptive measures during the study period.

Критерии исключения

• 1\. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
• 2\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• 3\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
• 4\. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
• 5\. CA199\>180 U/ml within 21d before adjuvant therapy;
• 6\. Known allergy to prescription or any component of the prescription used in this study;
• 7\. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
• 8 .Other reasons that are not suitable to participate in this study according to the researcher\'s judgment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Provincial People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT06722911 · IST-Nim-PC-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗