Hepatic Artery Infusion (HAI) Program at Duke University
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients Treated
研究概览
简要总结
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.
详细描述
This protocol is an interventional study for HAI therapy at Duke. The protocol is essentially for clinical treatment and the Investigator is not collecting safety and effectiveness data on the device itself. There are three primary indications for the hepatic artery infusion pump. The first are patients with unresectable, metastatic, liver-only or -dominant colorectal cancer. Although conversion to resection is a primary goal in these patients, most of these patients will die of liver disease and therefore controlling liver disease is a secondary goal to improve survival. The second group of patients are those with resectable, but high risk metastatic, liver-only or -dominant colorectal cancer. These patients are at high risk for liver recurrence, and HAI has demonstrated significant improvement in outcomes. The last group are patients with unresectable primary liver cancer, primarily intrahepatic cholangiocarcinoma. These patients have central tumors that are rarely resectable.
Eligible patients will have the following procedures performed during this study.
- On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
- During the hospital stay, patients will have:
- Daily physical examination to evaluate for the development of complications
- Daily blood tests to evaluate blood cell counts and liver function
- Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
- Assessment of side effects
Follow-Up Visits
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
- •Patients age 18-80
- •Eastern Cooperative Oncology Group score 0-1
- •Fit for major surgery
- •Without evidence of cirrhosis or portal hypertension
- •Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
- •Disease should be liver-only or liver-dominant
- •Arterial anatomy must be suitable, determined by the surgeon
- •Primary tumor may be in place in the case of colorectal liver metastases. Patients may have colorectal liver metastases (unresectable, borderline resectable, resectable), or unresectable intrahepatic cholangiocarcinoma.
- •Chemotherapy completed at least 3 weeks prior to surgery.
排除标准
- •Patients younger than 18 or older than 80 years
- •Eastern Cooperative Oncology Group score 2+
- •Unfit for major surgery
- •Inherent liver disease with evidence of cirrhosis or portal hypertension
- •Widely metastatic disease is absolutely contraindicated
- •Pregnant women (Women of childbearing potential who have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed and have a partner who is able to father children will have a blood or urine pregnancy test performed, and it must be negative in order to continue in the study.)
结局指标
主要结局
Number of patients Treated
时间窗: Surgery to 6 months post-surgery
Number of patients who completed HAI therapy
次要结局
- Serious Adverse Events(Surgery to one year post-surgery)
研究者
Michael Lidsky, M.D.
Assistant Professor of Surgery
Duke University