A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Two-year Disease-free Survival
研究概览
简要总结
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (<1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg/m² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg/m² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years, < 80 years
- •Patients with primary surgical treatment
- •Postoperative pathology confirmed intrahepatic cholangiocarcinoma
- •Postoperative pathology showing narrow resection margin (<1cm) or positive lymph nodes
- •R0/R1 resection
- •Postoperative Child-Pugh score A5-B7
- •Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation
- •Lymph node metastasis accounting for >50% of dissected nodes
- •Lymph node metastasis involving the paracardial region or below the renal vein level
- •Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules
- •Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2
- •Estimated life expectancy >3 months
排除标准
- •History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- •Had prior abdominal irradiation
- •Had prior liver transplantation
- •Had serious myocardial disease or renal failure
- •Had moderate or severe ascites with obvious symptoms 4 months after surgery
- •Duration from surgery ≥ 4 months
研究组 & 干预措施
Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
干预措施: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost (Radiation)
结局指标
主要结局
Two-year Disease-free Survival
时间窗: up to 24 months
Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death
次要结局
- Local-Regional Control Rate(up to 24 months)
- Incidence of Grade 3 or Higher Adverse Events(up to 24 months)
- Two-year Overall Survival(up to 24 months)
- Local-Regional Control Rate(up to 24 months)
- Incidence of Grade 3 or Higher Adverse Events(up to 24 months)
研究者
BO CHEN
Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences