A Single-arm, Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract Cancer(BTC) With High Risk of Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 2-year recurrence-free survival rate
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence
详细描述
Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment.
This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance，then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle.
If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.
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, both males and females are eligible.
- •Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
- •TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
- •Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
- •Time between surgery and enrollment < 12 weeks.
- •R0 resection.
- •No distant metastasis confirmed by MRI.
- •Adequate organ and marrow function, as defined below. Haemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Serum bilirubin ≤ 1.0 × ULN ALT and AST ≤ 2.5 × ULN Calculated creatinine clearance > 50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance.
排除标准
- •Patient diagnosed with Ampulla of Vater(AoV).
- •Time between surgery and enrollment >12 weeks.
- •Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
- •The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
- •Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
- •Severe infection within 4 weeks before enrollment.
- •Participated in another interventional clinical study.
- •Other factors deemed by the investigator to make the participant unsuitable for participation in this study.
研究组 & 干预措施
Durvalumab combined with S-1
Durvalumab combined with S-1
干预措施: Durvalumab combined with S-1 (Drug)
结局指标
主要结局
2-year recurrence-free survival rate
时间窗: 2 years
The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery.
次要结局
- 3-year overall survival rate(3-year OS rate)(3 years)
- Overall survival（OS）(3 years)
- Recurrence-free survival(RFS)(2 years)
- Safety and tolerability by incidence, severity and outcome of adverse events(3 years)