NCT04943653招募中1 期
Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- 6-month progression free survival (6-month PFS)
研究概览
简要总结
IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis.
Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
- •pathologically proven primary gastric adenocarcinoma
- •peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
- •written informed consent
- •adequate function of important organs (within 14 days before registration)
- •Absolute neutrophil count ≥1.5 x 10^9/L, Platelet >=100,000/mm3, Hemoglobin >=8.0g/dL, Total bilirubin <= ≤ 2.0mg/dl or ULN(Upper Limit of Normal) x 1.5, AST(aspartate aminotransferase) <=100IU/L(International Unit/Liter), ALT(alanine transaminase) <=100IU/L, Creatinine clearance ≥ 50mL/min (milliliter/minute),
排除标准
- •other active concomitant malignancies
- •HER2(human epidermal growth factor receptor 2) positive (Immunohistochemistry 3+ or 2+ with in situ hybridization positive)
- •no investigational anticancer therapy within 30 days prior to the first dose of study treatment
- •recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
- •uncontrolled acute or chronic disease
- •uncontrolled infection or inflammation
- •uncontrolled psychiatric disorder or central neurologic disease
- •not fully recovered from previous surgery
- •prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
- •intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
- •fertile males and females who are unwilling to use effective contraceptive methods.
- •pregnancy, breast feeding or intention to become pregnant
- •interstitial pneumonia or pulmonary fibrosis
- •peripheral neuropathy with functional impairment
- •hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL.
- •concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4
- •concomitant therapy with sorivudine or brivudine
- •Dihydropyrimidine dehydrogenase (DPD) deficiency.
- •current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium
研究组 & 干预措施
Intraperitoneal paclitaxel + XELOX
Experimental
Intraperitoneal paclitaxel Day1, Day8 + *XELOX
*XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks
干预措施: Paclitaxel (Drug)
结局指标
主要结局
6-month progression free survival (6-month PFS)
时间窗: 6 months after start of treatment
PFS is the time from date of first dose until the date of objective disease progression or death
次要结局
- Objective Response Rate (ORR)(6 months after start of treatment)
- Conversion surgery rate(6 months after start of treatment)
- 1-year overall survival (1-year OS)(1 year after start of treatment)
- Ascites response(6 months after start of treatment)
研究者
In-ho Kim
Associate proffessor
Seoul St. Mary's Hospital
研究点 (1)
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