NCT03175016Unknown2 期
Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tumor Response of four months
研究概览
简要总结
This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- •Patients with primary colorectal lesions removed, and negative extrahepatic metastasis
- •Patients with at least one measurable liver metastases, with size > 2cm or less than 5 liver metastases,with size smaller than 10cm.
- •Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
- •No intervention therapy was received for liver lesions during one year.
- •Life expectancy of > 3 months
- •Child-pugh's grade A or B (no more than 7 score).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2
- •Signed, written informed consent
排除标准
- •Patients with extrahepatic metastasis
- •Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
- •With obvious arterio-venous fistula
- •Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
- •Hematologic function: leukocytes <3000cell/mm3, platelets<50000/mm3, with no hypersplenism.
- •Adequate renal function (creatinine ≤ 2.0mg/dl)
- •Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) >5 times upper limit of normal(ULN)
- •International Normalized Ratio (INR) >1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
- •With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- •With recent infections and received antibiotics.
- •Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
研究组 & 干预措施
DEBIRI
Experimental
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
干预措施: TACE (Procedure)
DEBIRI
Experimental
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
干预措施: Irinotecan (Drug)
DEBIRI
Experimental
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
干预措施: eluting-bead (Device)
结局指标
主要结局
Tumor Response of four months
时间窗: four months post first treatment
Response rate(RR)
Tumor Response of two months
时间窗: Two months post first treatment
Response rate(RR)
Tumor Response of six months
时间窗: Six months post first treatment
Response rate(RR)
次要结局
- Time to intrahepatic progression(From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months)
- Time to extrahepatic progression(From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months)
- overall survival(From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months)
- Quality of life(Six months post first treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and BevacizumabColon Cancer With Metastases to the LiverNCT00932438University of Louisville70
进行中（未招募）
早期 1 期
A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT05560399Icahn School of Medicine at Mount Sinai7
招募中
1 期
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical ResectionHCCNCT06560827CARsgen Therapeutics Co., Ltd.30
已完成
1 期
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck CancersRecurrent Head and Neck CancerMetastatic Head and Neck CancerNCT04902027CSPC ZhongQi Pharmaceutical Technology Co., Ltd.45
终止
1 期
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian CancerPlatinum-resistant Ovarian CancerNCT04718376CSPC ZhongQi Pharmaceutical Technology Co., Ltd.56