CTRI/2011/07/001917已完成2 期
An open label, multi-centre, non-randomized, single arm study to evaluate the safety and efficacy of APCEDEN? [Dendritic Cell (DC) immunotherapy] in patients with refractory solid malignancies, on symptomatic treatment. - ATESST (Apceden Therapy: Efficacy and Safety in Solid Tumors)
APAC BIOTECH PVTLTD0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
入选标准
- •1.Male and female subjects from 18 to 70 years of age
- •2.Histologically confirmed refractory solid tumors on symptomatic care
- •3.Available tumor tissue: embedded in paraffin blocks and/or unstained slides
- •4.Life expectancy at least 3 months
- •5.ECOG status less than 2
- •6.Adequate Organ function:
- •A.Liver function:
- •i.In the absence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 2 times ULN
- •ii.In the presence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 5 times ULN
- •iii.Alkaline phosphatase less than equal to 2.5 times ULN
- •iv. Albumin more than equal to 3.0 g/dL
- •B.Renal function:
- •i.Serum creatinine less than equal to 1.5 times ULN
- •ii.No active acute or chronic urinary tract infection
- •iii.Urinalysis with no evidence of proteinuria
- •C.Hematology Status:
- •i.Platelet count more than equal to 100,000 platelet/cumm (100 ×109/L)
- •ii.Hemoglobin more than equal to 9 g/dL.
- •iii.WBC more than equal to 3,000/cumm
- •D.Coagulation Profile:
- •i.Acceptable coagulation profile (PT or INR, PTT) less than 1.5 times ULN
- •E.Serum immune-globulins IgA and IgM within normal range
- •7.No blood transfusion within 4 weeks of joining the study.
- •8.No exposure to immunotherapy and cancer Immunotherapy
- •9.Females of child bearing potential must have negative urine pregnancy test at screening
- •10.Child bearing potential participants to exercise effective birth control measures
- •11.Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site.
排除标准
- •1.Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment
- •2.Exposure to any investigational agent within 30 days of the Screening Visit.
- •3.Central Nervous System Metastases
- •4.Known Autoimmune disease or disease process that involves the use of immunosuppressive therapy
- •5.Patients on long-term steroid therapy (more than one week)
- •6.Underlying Cardiac disease associated with New York Heart Association Class III and IV function or unstable angina related to atherosclerotic cardiovascular disease
- •7.Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis
- •8.Known HIV infection
- •9.Active Hepatitis
- •10.Active Tuberculosis
- •11.Any Uncontrolled active, infection.
- •12.Substance abuse or any condition that might interfere with the subject?s participation in the study or in the evaluation of the study results.
- •13.History of hypersensitivity to Immunotherapy such as asthma, anaphylaxis or other severe reactions
- •14.Any medical, psychological, sociological or geographical constraints judged by the investigator that would impede patients compliance to the study procedures
研究者
相似试验
已完成
1 期
A study to assess the effect of oral insulin on safety, tolerability, effect of oral insulin on the blood sugar level and effect of oral insulin on the body in typeI Diabetes mellitus patients.CTRI/2009/091/001008Biocon Research Limited28
进行中（未招募）
不适用
Continuation of cholic acid treatment for people with bile acid disorders who have previously taken part in clinical trials of cholic acid capsules.Patients with inborn errors of bile acid synthesis and metabolismMedDRA version: 14.0Level: PTClassification code 10070882Term: Inborn error in primary bile acid synthesisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-004528-36-Outside-EU/EEAAsklepion Pharmaceuticals, LLC30
进行中（未招募）
不适用
An open label, single center, non-randomised, phase II study of efficacy Olaparib in patients with BRCA mutation posistive previously treated advanced ocarium canceradvanced ovarian cancerMedDRA version: 17.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002014-22-HUOrszágos Onkológiai Intézet
已完成
3 期
A clinical trial to study the efficacy and safety of topical gel containing fixed dose combination of Amitriptyline, Lidocaine and Capsaicin in treatment of neurogenic pain associated with localized peripheral neuropathies.CTRI/2010/091/001458upin Limited India220
尚未招募
3 期
The implantable tissues intended for human recipients for correcting cardiovascular abnormalitiesCTRI/2017/08/009225Frontier Lifeline Hospital