Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma

Официальное название

Endoscopic Ultrasound-guided Intratumoral Iodine125-Seeds Implantation Combined With Gem/Nab-P Chemotherapy Versus Gem/Nab-P Alone for Metastatic Pancreatic Carcinoma: a Randomized, Controlled, Trial

Обзор

The goal of this clinical trial is to evaluate the clinical efficacy and safety of endoscopic ultrasonography (EUS)-guided radioactive iodine 125 seeds in combination with AG regimen chemotherapy for the treatment of metastatic pancreatic cancer. The main questions it aims to answer are: * whether the combination of minimally invasive endoscopy-guided local radiation therapy with chemotherapy may improve overall survival * the adverse events of the combination therapy Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gem/nab-P given on days 1 and 8 of each 21-day cycle will be conducted. Researchers will compare the I125+AG group with the group that takes AG chemotherapy alone to see if the overall survival can be improved.

Вмешательства

• Процедура Iodine125-Seeds implantation
  Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
• Препарат Gem/nab-P Chemotherapy
  nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8 every 3 weeks

Первичные конечные точки

• Overall survival (OS) [Срок оценки: 48 months]

Вторичные конечные точки (6)

• Incidence and severity of Adverse events (AEs) [Срок оценки: 48 months]
• Progression-free survival (PFS) [Срок оценки: 48 months]
• Overall Response Rate (ORR) [Срок оценки: 48 months]
• CA19-9 response [Срок оценки: 48 months]
• Metabolic response [Срок оценки: from baseline to the end of 2nd chemotherapy cycle]
• Visual analog scale (VAS) [Срок оценки: 48 months]

Критерии участия

Критерии включения

(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)

• 18 to 80 years old;
• Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed by clinical, imaging, and pathology, and the primary and metastatic mass can be measured on imaging.
• No treatment history of chemotherapy, radiotherapy, or surgery
• Expected survival > 6 months
• ECGO score of 0-2
• Eligible for chemotherapy (white blood cell > 3.5×109/L, neutrophil value > 1.5×109/L, hemoglobin > 80g/L, platelets > 100×109/L, albumin > 25g/L, alanine aminotransferase or aspartate aminotransferase ≤ 3 times the upper limit of normal and total bilirubin level ≤ 34.2umol/L, creatinine < 176.8 umol/L, normal ECG)
• Signed written informed consent;

Критерии исключения

• Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path)
• Pregnant or breastfeeding
• Presence of brain metastases
• Presence of deep vein thrombosis or pulmonary embolism
• Presence of HIV, HBV, HCV infection or other uncontrollable active infection
• Hypersensitivity to chemotherapy drugs
• History of other malignancies within 5 years
• Peripheral neuropathy or interstitial lung disease within 5 years
• Patient is enrolled in any other clinical protocol or investigational trial.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT05869474 · 2022-219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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