Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Официальное название

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Обзор

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 GX for postoperative adjuvant treatment of pancreatic cancer.

Подробное описание

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 GX (gemcitabine plus capecitabine) compared with GX only for resected pancreatic cancer. About 146 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus GX) and control group (placebo plus GX) at a ratio of 1:1. The main endpoint is relapse-free survival (RFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

Вмешательства

• Препарат Nimotuzumab
  Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.
• Препарат GX
  Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 days' rest.
• Препарат Placebo
  Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.

Первичные конечные точки

• relapse-free survival (RFS) [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\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^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;
• 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• 7\. Postoperative survival is expected to be ≥3 months;
• 8\. 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\. 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; gastric outlet obstruction; Respiratory insufficiency and Severe lung disease; Central Nervous System Disease or mental illness;
• 3\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• 4\. bleeding or clotting disorder;
• 5.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;
• 6\. Known allergy to prescription or any component of the prescription used in this study;
• 7\. Factors that significantly affect oral drug absorption, such as dysphagia, chronic diarrhea, gastrointestinal obstruction, etc;
• 8\. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
• 9.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

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06409429 · IST-Nim-PC-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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