ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3-Year Recurrence-Free Survival (RFS)
研究概览
简要总结
This prospective, single-arm exploratory study evaluates the feasibility and safety of a novel ICG-Cisplatin self-assembled nanoprobe (NIR-II NanoM) for fluorescence-guided surgery in patients with Hepatocellular Carcinoma (HCC). Participants will receive a transarterial injection of the nanoprobe mixed with lipiodol prior to surgery. During the subsequent laparoscopic anatomic hepatectomy, surgeons will utilize a Near-Infrared II (NIR-II) imaging system to visualize tumor boundaries and liver segments for precise resection.
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
- •Age 18-75 years.
- •First diagnosis of Hepatocellular Carcinoma (HCC) (non-recurrent).
- •Single tumor with diameter ≤ 5 cm.
- •Assessed as resectable by more than 2 senior liver surgeons (experience >10 years, >500 hepatectomies).
- •No distant metastasis on preoperative chest CT and abdominal contrast-enhanced CT.
- •Child-Pugh Class A liver function.
- •Patient or legal guardian able to understand the study and sign informed consent.
排除标准
- •Postoperative pathology confirms cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma.
- •Presence of portal vein, hepatic vein, or bile duct tumor thrombus.
- •History of other malignancies (except cured carcinoma in situ of cervix, basal cell carcinoma, or squamous cell skin carcinoma).
- •Evidence of residual lesion, recurrence, or metastasis during preoperative assessment; or postoperative pathology confirming lymph node metastasis or positive margins.
- •Moderate to severe ascites requiring therapeutic paracentesis/drainage, or Child-Pugh score > 7 (except for small amount of ascites on imaging without clinical symptoms).
- •Uncontrolled or moderate/large amount of pleural effusion or pericardial effusion.
- •Severe cardiac, pulmonary, or renal dysfunction.
- •Ruptured HCC requiring emergency surgery.
- •Patient or family unable to understand the study conditions and objectives.
研究组 & 干预措施
Experimental: NIR-II NanoM Group
Patients receive transarterial embolization (TAE) with ICG-Cisplatin self-assembled nanoprobes (NIR-II NanoM) mixed with lipiodol, followed by fluorescence-guided laparoscopic anatomic hepatectomy.
干预措施: ICG-Cisplatin Nanoprobe (NIR-II NanoM) (Drug)
Experimental: NIR-II NanoM Group
Patients receive transarterial embolization (TAE) with ICG-Cisplatin self-assembled nanoprobes (NIR-II NanoM) mixed with lipiodol, followed by fluorescence-guided laparoscopic anatomic hepatectomy.
干预措施: Fluorescence-guided Hepatectomy (Procedure)
结局指标
主要结局
3-Year Recurrence-Free Survival (RFS)
时间窗: Up to 3 years post-surgery
Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause.
Rate of Successful Fluorescence Staining
时间窗: Intraoperative (Day 0)
The proportion of participants with successful visualization of the tumor. Success is defined as the NIR-II nanoprobe showing clear fluorescence signals in the tumor tissue under the NIR-II imaging system during surgery, enabling the surgeon to distinguish tumor boundaries and liver segments for precise resection.
次要结局
- Overall Survival (OS)(From date of surgery up to 3-5 years)
- Incidence of Perioperative Adverse Events and Complications(From enrollment through 30 days post-surgery)
- Rate of Local Recurrence(From date of surgery up to 3 years)
- Rate of Distant Metastasis(From date of surgery up to 3 years)
研究者
Jiwei Huang
Clinical Professor
West China Hospital