JPRN-jRCT2073210118招募中2 期
Phase II trial of Survivin-responsive conditionally replicating adenovirus (Surv.m-CRA-1) by repeated local administration in patients with advanced primary malignant bone tumor. - SURV-B-study
agano Satoshi0 个研究点目标入组 20 人开始时间: 2022年1月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- >= 10age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1)Pathologically diagnosed as primary malignant bone tumor
- •2)If standard treatment is preceded, More than 4 weeks has passed since prior standard treatment.
- •3)Not eligible for generally-accepted standard treatment that may achieve life-lengthening or palliative effect.
- •4)With a lesion measurable disease of short, long diameters and height and the lesion can be to be intratumorally injected with Surv.m-CRA-1.
- •5)Aged 10 years or older and younger than 85 years at the time of the consent.
- •6)ECOG performance status of 0-2.
- •7)Life expectancy for longer than 3 months.
- •8)Adequate organ function as defined below (Most recent test result in two weeks from registration)
- •Hb >= 7 g/dL
- •WBC >= 2,000 /microL
- •Plt >= 50,000 /microL
- •AST (GOT) =< 100 U/L
- •ALT (GPT) =< 100U/L
- •Total BIl. =< 2.0 mg/dL
- •Serum Cr. =< 2.0 mg/dL
- •9) Use of effective contraception, if procreative potential exists.
- •10) Provide written informed consent Written consent for participation for the trial is obtained from the patient or proxy.
排除标准
- •1) Patients with the following illness with any comorbidity
- •Severe heart disease, respiratory disease, digestive disease or liver disease.
- •Uncontrolled diabetes
- •Infectious disease that needs continuous treatment
- •2) A history of allergic reactions History of allergy to penicillin, pork or beef (including milk)
- •3) Ongoing illness that needs requires immunosuppressant or corticosteroid administration
- •4) Active double cancer (Excluding resected basal cell carcinoma, intraepithelial carcinoma, superficial bladder carcinoma, or malignant tumor relapse-free for more than 5 years)
- •5) Uncontrollable fever or pain from the tumor
- •6) Pregnant, breast-feeding or woman with positive for pregnancy test woman before or less than within 1 year from after menopause.
- •7) Treated with non-approved drug in less than within 4 weeks before consent of study entry.
研究者
相似试验
招募中
2 期
Cisplatin and oral vinorelbine chemotherapy along with radiation for treatment of locally advanced lung cancerStage III Non Small Cell Lung CancerCancer - Lung - Non small cellACTRN12609000003279Royal Adelaide Hospital50
招募中
不适用
A Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)metastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)Cancer - Bowel - Small bowel (duodenum and ileum)ACTRN12621001198819Cancer Council Victoria50
进行中（未招募）
2 期
ImmunoTACEHepacellular CarcinomaLiverCancerISRCTN11889464niversity of Birmingham (UK)48
进行中（未招募）
1 期
A study comparing the standard treatment of transarterial chemoembolisation (TACE)plus low doses of chemotherapy (cyclophosphamide) with an immune cell derived vaccineHepatocellular carcinomaEUCTR2011-001690-62-GBniversity of Birmingham48
招募中
不适用
Phase II clinical trial for the effectiveness and safety of AW-PD01 (helium / oxygen mixed gas) for respiratory failure in children and infants with airway stenotic lesions: Single facility single group open label intervention studyRespiratory failure, BronchiolitisJPRN-UMIN000025065Tokyo Metropolitan Children's Medical Center10