KCT0003607已完成未知
A phase II study of first line intraperitoneal paclitaxel in combination with systemic S-1 and cisplatin in advanced gastric cancer with peritoneal dissemination and ascites.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. advanced gastric cancer confirmed as histological and/or cytological adenocarcinoma
- •2. gastric cancer patients who have peritoneal metastasis by imaging study(CT or MRI) and acites by imgaging study or physical exam.
- •3. patients who did not undergo operation or systemic chemotherapy for recrurrent/metastatic advance gastric cancer. Patients who had previously undergone surgical resection and adjuvant chemotherapy in local or locally advanced gastric cancer should have recurred 6 months after the end of adjuvant chemotherapy.
- •4. patients with ascitic peritoneal metastasis who can not undergo radical surgical resection.
- •5. patients who are able to understand and write the informed consent form.
- •6. has evaluable lesions by Response Evaluation Criteria in Solid Tumors Version(RECIST) 1.1
- •7. patients who agree to provide the specimens of tumor by endoscopic biopsy or resected specimen and agree to conduct the patient-derived gastric cancer model using ascitic specimen
- •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •9. Has adquate organ function
- •10. females of childbearing potential must have a negative serum or urine pregnancy test at screening and agree to use contraceptives during treatment.
排除标准
- •1. Patients who had previously undergone systemic chemotherapy for recurrent / metastatic advanced gastric cancer
- •2. Patients with HER2(human epidermal growth facter receptor 2)-positive gastric cancer.
- •3. is currentily participating in or has paticipated in a study of an investigatinal agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •4. patients who received chemotherapy, TKI(Tyrosine kinase inhibitor), or radiation within 2weeks prior to the first day of the study and patients who have not yet recovered adverse event(below GI(Gastro-intestinal) or baseline) due to a previously administered drug.
- •5. has a known additional malignancy that is progressing or has required actie treatment within the past 3 years. participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, or thyroid cancer that have undergone potentially curative therapy are not excluded.
- •6. has known active CNS(Central nervous system) metastasis and/or leptomeningeal seeding.
- •7. has an active autoimmune disease that has required systemic treatment in past 2 years.
- •8. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in best interest of the participant to participate, in the opinion of the treating investigator.
- •9. has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- •10. pregrant or breastfeeding or expecting to conceive or father children with the projected duration of the study, starging with the screening visit through 120 days after the last dose of chemotherapy.
- •11. has a knwon history of HIV(human immunodeficiency virus) infection
- •12. has active B-viral hepatitis or C-viral hepatitis
- •13. has received a live vaccine within 30 days prior to the first dose of study intervention.
- •14. has an active infection requiring systemic therapy.
- •15. has a history of hypersensitivity or serious adverse reaction to S-1, cisplatin, or paclitaxel.
- •16. patients with contraindications to the use of S-1, cisplatin, or paclitaxel.
研究者
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