NCT05220124招募中4 期
An Open Label, Randomized Control Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
Tianjin Medical University Second Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年1月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.
详细描述
To evaluate the progression free survival of intestinal probiotics in immunotherapy for urothelial carcinoma. Changes in fecal flora abundance before and after treatment were assessed to identify subjects most likely to benefit from enteric probiotics treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with urothelial carcinoma and undergoing immunotherapy ;
- •Age ≥ 18 years;
- •Expected survival time is greater than 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2;
- •Organ function level must meet the following requirements:
- •Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by symptomatic treatment); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=2.5 ULN (can be maintained by symptomatic treatment);
- •The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
- •Willing and able to provide written informed consent.
排除标准
- •Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
- •Active, known or suspected autoimmune diseases;
- •Cannot take orally or are allergic to probiotics ;
- •History of primary immunodeficiency ;
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •Pregnant or lactating female patients;
- •Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
- •Uncontrolled concurrent diseases, including but not limited to:
- •HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [hypertension greater than or equal to conmon terminology criteria for adverse events （CTCAE） grade 2 after drug treatment]); Patients with active bleeding or new thrombotic disease.
研究组 & 干预措施
Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
Experimental
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.
干预措施: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 3 years
Time from randomness to the first occurrence of disease progression or death from any cause.
次要结局
- Duration of Response (DOR)(up to 3 years)
- Overall Survival (OS)(up to 3 years)
- Serious Adverse Event (SAE)(up to 3 years)
- Overall response rate (ORR)(up to 3 years)
- Disease control rate (DCR)(up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Randomized Controlled Field Trial of a Probiotics to Assess Its Role in Preventig DiarrhoeaDiarrheaNCT00534170Indian Council of Medical Research4,000
尚未招募
不适用
Het effect van probiotica op vitamine K statusNL-OMON21670VU medical center Amsterdam20
撤回
2 期
A randomized pilot study on probiotics and their effect on vitamin K2 status10047635vitamine statusnutritional statusvitamin K statusNL-OMON46101Winclove B.V.20
尚未招募
不适用
A Study on Probiotic Formula in Autistic ChildrenAutism Spectrum DisorderNCT06419530Third Military Medical University156
尚未招募
3 期
Probiotics in the prevention of lung infection in patients on a ventilator.CTRI/2019/04/018659Fluid researchCMC vellore