jRCT2073220017招募中不适用
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)
未提供0 个研究点目标入组 96 人开始时间: 2022年10月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 主要终点
- Presence or absence of DLT expression
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.
- •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)
- •Abdominal port placement is possible
- •No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
- •Diagnosed gastric adenocarcinoma or pancreatic cancerwith by histological or cytological examination
- •The patient has been confirmed to be "negative (not MSS = MSI-high)" by microsatellite instability (MSI) testing, or "proficient mismatch repair (pMMR)" by mismatch repair protein immunohistochemistry testing
- •Eastern Cooperative Oncology Group (ECOG) Performance status(PS) 0-2
- •Patient aged 20years or older
- •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
- •Expected to survive for 3 months or more at the enrollment
- •Written informed consent
排除标准
- •Untreated cranial metastases.
- •Diagnosed with meningeal carcinomatosis
- •Received allogeneic hematopoietic stem cell transplantation
- •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.
- •Existence or suspected active autoimmune disease
- •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
- •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.
- •Have active double cancer and need treatment for the double cancer
- •Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period
- •Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
- •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
- •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
- •Scheduled thoracotomy or abdominal surgery during the clinical trial period
- •It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
- •Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
- •Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
- •Difficult to participate in the trial by the investigator
结局指标
主要结局
Presence or absence of DLT expression
Presence or absence of DLT expression
Frequency and severity of adverse events
Frequency and severity of adverse events
Survival rate at 6 months for gastric and pancreatic cancer patients
时间窗: 6 months
Survival rate at 6 months for gastric and pancreatic cancer patients
次要结局
- Pharmacokinetics of GAIA-102
- Research of Biomarkers
研究者
相似试验
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)Advanced gastrointestinal cancer of microsatellite stablegastric cancer, pancreatic cancerGastrointestinal NeoplasmsJPRN-jRCT2073220017Eiji Oki96
招募中
1 期
A phase 1 clinical trial of intraperitoneal administration of iCAR-ILC/N101 for ovarian clear cell carcinomaPatients with GPC3-expressing advanced ovarian clear cell carcinoma with peritoneal disseminationovarian clear cell carcinomaJPRN-jRCT2033200431Harano Kenichi18
已完成
不适用
A study to know the effect of instillation of local anesthetic agent ,bupivacaine in abdomen for reliefof pain after cesarean sectioCTRI/2017/01/007679Government medical college surat100
招募中
不适用
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patientscancerJPRN-UMIN000034123Ashiya Municipal Hospital15
尚未招募
4 期
A clinical trial to study the efficacy of local anesthetic drug bupivacaine injected at the site of instrument entry in the abdomen during laparoscopic sterilization in femalesCTRI/2018/10/015982Dr Aniket Kakade