Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

Официальное название

Gemcitabine and Nab-paclitaxel Venous Injection Plus Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

Обзор

The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to Patients with Advanced Pancreatic Cancer.

Подробное описание

Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The MPACT trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.

Regional intra-arterial infusion chemotherapy helps to deliver anticancer drugs into the carcinoma tissue more selectively and is considered to be a potential alternative treatment for advanced pancreatic adenocarcinoma with less systemic adverse effects. Ohigashi et al first reported that intraarterial chemotherapy using 5-fluorouracil improved the prognosis and quality of life in patients with advanced pancreatic carcinoma.

The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to patients with advanced pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.

Вмешательства

• Препарат Gemcitabine
  1000 mg per square meter
• Препарат Nab paclitaxel
  120 mg per square meter of body-surface area

Первичные конечные точки

• Overall survival，OS [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]

Вторичные конечные точки (3)

• progression-free survival, PFS [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• objective response rate (ORR), [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• disease control rate (DCR) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]

Критерии участия

Критерии включения

• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥ 18 years and ≤ 80 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
• Primary pancreatic cancer without major anti-cancer treatments.
• Locally advanced, or metastatic pancreatic cancer.
• Presence of at least of one measurable lesion in agreement to RECIST criteria.
• The expected survival ≥ 3 months.
• Adequate organ performance based on laboratory blood tests.
• Patients who are willing or able to comply with study procedures.

Критерии исключения

• Pregnant or nursing women.
• Patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments.
• The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
• Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
• Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
• Cardiovascular and cerebrovascular accidents.
• Allergic to study drugs.
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

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

• Shanghai Cancer Center — Шанхай

Публикации

• Aigner KR, Gailhofer S, Selak E, Aigner K. Intra-arterial infusion chemotherapy versus isolated upper abdominal perfusion for advanced pancreatic cancer: a retrospective cohort study on 454 patients. J Cancer Res Clin Oncol. 2019 Nov;145(11):2855-2862. doi: 10.1007/s00432-019-03019-6. Epub 2019 Sep 10. PMID 31506738
• Liu X, Yang X, Zhou G, Chen Y, Li C, Wang X. Gemcitabine-Based Regional Intra-Arterial Infusion Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma. Medicine (Baltimore). 2016 Mar;95(11):e3098. doi: 10.1097/MD.0000000000003098. PMID 26986149
• Endo S, Kawaguchi S, Terada S, Shirane N. Hepatic Arterial Infusion Chemotherapy for Liver Metastases Following Standard Chemotherapy for Pancreatic Cancer. Intern Med. 2021 Jan 15;60(2):223-229. doi: 10.2169/internalmedicine.5449-20. Epub 2020 Sep 19. PMID 32963157
• Qiu B, Zhang X, Tsauo J, Zhao H, Gong T, Li J, Li X. Transcatheter arterial infusion for pancreatic cancer: a 10-year National Cancer Center experience in 115 patients and literature review. Abdom Radiol (NY). 2019 Aug;44(8):2801-2808. doi: 10.1007/s00261-019-02022-2. PMID 31025067

Идентификаторы

NCT: NCT06196788 · PTCA199-9

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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