Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1
研究概览
简要总结
In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.
详细描述
In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of cholangiocarcinoma
- •Not eligible for curative surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
- •No serious or uncontrolled concomitant medical illness
- •Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧75,000/ul)
- •Consent this study in letter
排除标准
- •Another neoplasia
- •Porphyria
- •Pregnant or breastfeeding women
研究组 & 干预措施
1
Treatment by combination of photodynamic therapy and S-1
- PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
- S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, <1.25m2: 80mg/day, 1.25~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
干预措施: S-1 Chemotherapy (Drug)
1
Treatment by combination of photodynamic therapy and S-1
- PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
- S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, <1.25m2: 80mg/day, 1.25~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
干预措施: Photodynamic therapy (Procedure)
2
Treatment by photodynamic therapy only
- PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
- Other managements except systemic chemotherapy were added freely.
干预措施: Photodynamic therapy (Procedure)
3
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
干预措施: Photodynamic therapy (Procedure)
3
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
干预措施: Systemic chemotherapy except S-1 (Procedure)
结局指标
主要结局
Compare overall survival time in patients with unresectable perihilar cholangiocarcinoma treated with photodynamic therapy combined with or without S-1
时间窗: 12 months after study start
次要结局
- Compare the frequency of repeat photodynamic therapy(6 months after study start)
- Compare the frequency of hospitalization(6 months after study start)
- Compare the frequency of biliary tract decompressive interventions(6 months after study start)
研究者
Do Hyun Park
Assistant professor
Asan Medical Center