JPRN-jRCT2073220017招募中1 期
Clinical trial of repeated intraperitoneal administration of GAIA-102 in patients with advanced gastrointestinal cancer (gastric cancer / pancreatic cancer) of microsatellite stable (MSS) with malignant ascites (Phase I / II Investigator-initiated clinical trial) - GAIA-102_PD clinical trial
Eiji Oki0 个研究点目标入组 96 人开始时间: 2022年6月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Unresectable, advanced and relapsed gastric cancer with malignant ascites or unresectable, advanced and relapsed pancreatic cancer with malignant ascites
- •2. Refractory/intolerant to more than 3 regimens of therapy for gastric cancer (more than 2 regimens acceptable for Phase II) or more than 2 regimens of therapy for pancreatic cancer (more than 1 regimen acceptable for Phase II)
- •3. Abdominal port placement is possible
- •4. No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
- •5. Diagnosed gastric adenocarcinoma or pancreatic cancerwith by histological or cytological examination
- •6. Negative (MSS= not MSI-high) by microsatellite instability test
- •7. Eastern Cooperative Oncology Group (ECOG) Performance status(PS) 0-2
- •8. Patient aged 20years or older
- •9. Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:
- •-Neutrophil >1,500/mm3
- •-hemoglobin >=8.0 g/dL
- •-Platelet >75,000/mm3
- •-PT-INR <1.5
- •-AST, ALT <=3 times the upper limit of reference value
- •-T-Bil <=2 times the upper limit of reference value
- •(T-Bil <=3.0mg/dL , when drainage for obstructive jaundice)
- •-eGFR >=30mL/min/1.73m2
- •10. Expected to survive for 3 months or more at the enrollment
- •11. Written informed consent
排除标准
- •1. Untreated cranial metastases.
- •2. Diagnosed with meningeal carcinomatosis
- •3. Received allogeneic hematopoietic stem cell transplantation
- •4. Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.
- •5. Existence or suspected active autoimmune disease
- •6. Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration
- •7. Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.
- •8. Have active double cancer and need treatment for the double cancer
- •9. Requires treatment as shown in Unacceptable Combination / Supportive Therapy during the during the clinical trial period
- •10. Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
- •11. Have one of the following complications
- •-Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment
- •-Active gastrointestinal perforation, fistula, diverticulitis
- •-Symptomatic congestive heart failure
- •-Bleeding tendency
- •-Presence of blood clots that may cause embolism on the image
- •-Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment
- •-Uncontrollable digestive ulcer
- •-Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents
- •-HIV antibody positive
- •12. At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.
- •-Surgery (including exploratory laparotomy / examination laparoscope): 2 weeks
- •-Palliative radiotherapy: 1 week
- •-Thoracic drainage: 1 week
- •-Pretreatment antineoplastic (from the last administration): 3 weeks
- •-Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks
- •13. Scheduled thoracotomy or abdominal surgery during the clinical trial period
- •14. It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
- •15. Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
- •16. Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
- •17. Difficult to participate in the trial by the investigator
研究者
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