NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection
West China Hospital
30 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria9
- 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.
Interventions
Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift\&NanICG), administered via superselective transarterial injection for tumor staining.
Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07295262