JPRN-jRCTs041220164招募中2 期
A phase II study of mFOLFOX6+Nivolumab as first-line treatment in gastric cancer with severe peritoneal metastasis - WJOG16322G
Masuishi Toshiki0 个研究点目标入组 55 人开始时间: 2023年3月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1.Written informed consent
- •2.Between the ages of 18 and 75 years
- •3.Histologically confirmed adenocarcinoma
- •4.HER2 negative or HER2 test IHC 2+ and FISH submitted.
- •5.Unresectable or recurrent gastric cancer with peritoneal metastasis
- •6.Patients without symptomatic brain or spinal code metastasis or meningeal dissemination
- •7.No pleural effusion needed to be removed
- •8.No fistula between tumor and other organ
- •9.Measurable or non-measurable disease
- •10.No previous chemotherapy for gastric cancer
- •11.No prior use of oxaliplatin.
- •12.No prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody. or no prior use of other antibodies or agents that specifically target T cell co-stimulatory or checkpoint pathways.
- •13.Patients' status of peritoneal metastasis or ECOG PS must meet following criteria.
- •(1)Patients with ECOG PS 0-2 who have massive ascites or inadequate oral intake.
- •(2)Patients with PS 0-1 who have massive ascites and inadequate oral intake.
- •14.The most recent laboratory values within 7 days prior to registration meet all of the following
- •(1)Number of neutrophils >= 1,500/mm3
- •(2)Hemoglobin >= 8.0 g/dL
- •(3)Platelet count >= 100,000/mm3
- •(4)Total bilirubin <= 1.5 mg/dL
- •(5)AST(GOT) <= 100 IU/L (<= 200 IU/L, if liver metastases are existed)
- •(6)ALT(GPT) <= 100 IU/L (<= 200 IU/L, if liver metastases are existed)
- •(7)Serum creatinine <= 1.5 mg/dL. Serum creatinine > 1.5 mg/dL is allowed if Ccr is >= 20 mL/min.
排除标准
- •1. HER2 positive AGC.
- •2. Patients with synchronous or metachronous multiple primary cancer.
- •3. Patients who require systematic therapy including corticosteroid > 10 mg/day or other immunosuppressive agent within 14 days before registration.
- •4. Patients with infection which should be treated
- •5. Psychiatric disease that is inappropriate for entry into this study
- •6. History of any medical condition as follows
- •(1) Renal insufficiency
- •(2) liver insufficiency
- •(3) Intestinal pneumonitis
- •(4) Autoimmune disease requiring treatment
- •(5) Myocardial infarction within the last 6 months or unstable angina pectoris within the last 3 weeks
- •(6) HBs Ag: positive
- •(7) Grade 2 or more peripheral sensory neuropathy
- •(8) Severe complication which investigators judge
- •7. Severe hypersensitivity
- •8. Pregnant or lactating female
- •9. Patients whom investigators judge inappropriate
研究者
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