Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma

Официальное название

The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma

Обзор

To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.

Вмешательства

• Препарат Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
  Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40\~60mg，bid, d1-14( BSA\<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA\>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\\PR\\SD and decided by the investigator to continue the treatment for two cycles or directly.

Первичные конечные точки

• R0 resection rate [Срок оценки: within 4 weeks following the operation]

Вторичные конечные точки (3)

• Progression free survival (PFS) [Срок оценки: 5 years]
• overall survival (OS) [Срок оценки: 5 years]
• Adverse Events(AEs) [Срок оценки: until 28 days after the last study drug administration]

Критерии участия

Критерии включения

• Age of 18-75 years; male or female.
• Karnofsky Performance Status Score ≥70.
• Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
• The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
• Physical condition and organ function allow for larger abdominal surgery.
• Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
• Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
• No serious accompanying disease lead to a survival period of <5 years.
• Agree and be able to follow the protocol during the study period.
• Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.

Критерии исключения

• For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
• Pregnancy or breastfeeding woman.
• Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
• Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
• Patients with ascites and positive abdominal free cancer cells.
• There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
• Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
• Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
• Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-1.
• It is known to have peripheral neuropathy ≥ NCI CTC AE grade 2. However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
• Organ transplantation requires immunosuppressive therapy.
• Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
• Moderate or severe renal impairment \[creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine > upper normal limit (ULN).
• Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
• Those who are allergic to taxanes or any research ingredients.
• Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.

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

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT04047953 · GC-conversion

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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