An Open Prospective Randomized Clinical Study of the Effectiveness, Tolerability and Safety of a Single Intraperitoneal Use of the Drug "Prospidelong, Powder for the Preparation of a Gel for Topical Use, 1000 mg in Vials, Package No. 1" in Patients With Disseminated Gastric Cancer, Phase I-II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- increased survival
研究概览
简要总结
It is planned to conduct an open-label, prospective, randomized clinical study of the efficacy, tolerability and safety of a single intraperitoneal administration of the investigational drug Prospidelong at a dose of 4000 mg (2000 mg in terms of prospidium chloride) in patients with disseminated gastric cancer.
In total, the study plans to include 120 patients aged 18 to 75 years inclusive, including 60 patients in the study group and 60 in the comparison group. The study consists of daily examination of patients throughout the entire period of hospitalization and subsequent visits.
详细描述
It is planned to conduct an open-label, prospective, randomized clinical study of the efficacy, tolerability and safety of a single intraperitoneal administration of the investigational drug Prospidelong at a dose of 4000 mg (2000 mg in terms of prospidium chloride) in patients with disseminated gastric cancer.
In total, the study plans to include 120 patients aged 18 to 75 years inclusive, including 60 patients in the study group and 60 in the comparison group. The study consists of daily examination of patients throughout the entire period of hospitalization and subsequent visits.
Inclusion - preliminary interview with the patient and signing of informed consent.
Informed consent is the free and voluntary expression of the subject's desire to participate in a specific study after receiving information about all aspects of this study that are significant for the subject's decision to participate, and in the case of minors and incapacitated subjects, the permission or consent of their legal representatives to include such subjects into the study. Informed consent is documented by signing and dating the informed consent form.
Signed and dated informed consent must be obtained from each patient or, if the patient is unable to make an informed decision due to health reasons, from the patient's spouse/close relative (close relatives include parents, adult children, siblings, grandparents) , grandchildren), and the patient's signed informed consent to participate in the study must additionally be obtained as soon as his health condition allows it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer without transition to the esophagus with peritoneal dissemination sT1-4N0-3M
- •Life expectancy of at least 6 months
- •Physical status on the ECOG scale 0 -
- •The age of patients is from 18 to 75 years.
- •Absence of severe concomitant diseases in the decompensation stage.
- •Availability of written informed consent from the patient to participate in the study.
- •The ability of the patient and the personnel caring for him to comply with the instructions of the research physician and comply with the study design.
排除标准
- •Pregnancy and lactation.
- •The presence of a primary multiple (synchronous or metachronous) malignant tumor. The exception is for patients who were treated for basal cell or squamous cell skin cancer, cervical cancer in situ, or other tumors more than 5 years ago and are expected to be completely cured.
- •Presence of severe concomitant diseases in the stage of decompensation;
- •Family relationships between the patient and the center staff.
- •Allergy to components of the study drug.
- •Refusal of the patient from the proposed treatment method.
- •Presence of heart disease class III or IV according to the New York Heart Association classification or a history of myocardial infarction within 6 months before the 1st day of the study.
- •Any history of epileptic seizures.
- •Severe diseases, including those with severe symptoms, untreated inflammatory and infectious processes, due to which the patient cannot receive treatment in accordance with the study protocol.
- •Chronic liver and/or kidney failure.
- •Legal incapacity or other circumstances due to which the patient or his immediate family are unable to understand the nature, scope and possible consequences of the treatment being carried out
- •Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with protocol requirements for treatment and follow-up.
- •History of abuse of alcohol or any chemical substances for 2 years up to the 10th day before the start of the study.
- •Patient participation in another clinical trial.
- •Non-inclusion criteria based on survey data:
- •Acute bleeding from the tumor.
- •Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.
- •Hemoglobin less than 80g per l.
- •Positive tests for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •Severe liver dysfunction - AST and ALT levels exceed the upper limit of normal by 5 times or more, bilirubin greater than or equal to 2.0 mg per dL (34.2 µmol per L).
- •Severe renal impairment - creatinine clearance less than 30 ml per minute, calculated using the Cockcroft-Gault formula - or the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.
- •Diabetes mellitus in a state of clinical and metabolic decompensation.
- •Criteria for exclusion (dropout) from the study:
- •Individual intolerance to drugs included in the treatment regimen.
- •The patient's desire to stop participating in the study.
- •Serious adverse events occurring in the patient during the study.
- •Violation by the patient of the research conditions of the investigational medicinal product (non-compliance).
- •Pregnancy.
- •Detection of a second malignant tumor
研究组 & 干预措施
Experimental arm
after diagnostic laparotomy/laparoscopy, a single intraperitoneal administration of the study drug Prospidelong, produced by UNITEHPROM BSU, Republic of Belarus, further in accordance with the protocols of the Ministry of Health of the Republic of Belarus for the treatment of patients with the corresponding pathology, systemic chemotherapy in accordance with the clinical protocol "Diagnosis and treatment of malignant neoplasms" (approved by Resolution of the Ministry of Health of the Republic of Belarus No. 60 of 07/06/2018).
干预措施: Prospidelong (Drug)
Experimental arm
after diagnostic laparotomy/laparoscopy, a single intraperitoneal administration of the study drug Prospidelong, produced by UNITEHPROM BSU, Republic of Belarus, further in accordance with the protocols of the Ministry of Health of the Republic of Belarus for the treatment of patients with the corresponding pathology, systemic chemotherapy in accordance with the clinical protocol "Diagnosis and treatment of malignant neoplasms" (approved by Resolution of the Ministry of Health of the Republic of Belarus No. 60 of 07/06/2018).
干预措施: chemotherapy (Procedure)
Comparison group
after diagnostic laparotomy/laparoscopy, systemic chemotherapy in accordance with the clinical protocol "Algorithms for the diagnosis and treatment of malignant neoplasms" (approved by Resolution of the Ministry of Health of the Republic of Belarus No. 60 of 07/06/2018), namely the section regulating the treatment of patients suffering from metastatic gastric cancer with the degree of prevalence of the tumor process corresponding to sT1-4N0-3M1.
干预措施: chemotherapy (Procedure)
结局指标
主要结局
increased survival
时间窗: through study completion, an average of 2 years
The criterion for the effectiveness of a single intraperitoneal administration of the investigational drug Prospidelong in patients with disseminated gastric cancer will be an increase in progression-free survival after use of the investigational drug Prospidelong. Progression of disseminated peritoneal tumors with documented evidence of an increase in the grade of disseminated peritoneal tumors (compared to baseline) on non-invasive intrascopic imaging (CT or MRI) will be considered as events in the calculation of progression-free survival for this clinical trial. abdominal cavity) and/or second-look laparotomy. In the latter case, assessment of the peritoneal tumor index P.H. will be mandatory. Sugarbaker. Second-look laparotomy will be planned in patients with no evidence of progression of the tumor process according to multislice computed tomography or magnetic resonance imaging of the abdominal cavity.
次要结局
- detailed general blood test(through study completion, an average of 2 years)
- Ultrasound and/or computed tomography of the abdominal cavity (if necessary)(through study completion, an average of 2 years)
- blood chemistry(through study completion, an average of 2 years)