Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

Официальное название

Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial

Обзор

This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.

Вмешательства

• Комбинированный продукт Palliative surgery after translational therapy
  A total, distal, or proximal gastrectomy with D1 lymph node dissection was done depending on tumour after translational therapy . location.
• Препарат Chemotheraoy along
  Patients receive only the prescribed chemotherapy.

Первичные конечные точки

• 2-year overall survival rate [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Age from 18 to 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically
• CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis
• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• Estimated survival time was over 3 months
• The major organs are functioning normally and meet the following criteria:

(1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):

• HB≥100g/L，
• WBC≥3×109/L
• ANC≥1.5×109/L，
• PLT≥100×109/L； （2）Biochemical tests must meet the following criteria：

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• BIL <1.5×upper limit of normal (ULN)，
• ALT and AST<2.5ULN，GPT≤1.5×ULN；
• Cr≤1ULN，Ccr >60ml/min
• Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug
• Did not participate in other clinical studies before and during treatment
• Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up

Критерии исключения

• History of other malignant disease within past five years
• History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation
• Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection
• Women during pregnancy or breast-feeding
• Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:

• NYHA class II or more serious heart failure
• unstable angina pectoris
• myocardial infarction within 1 year
• clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05230771 · FUGES-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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