NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
NCT ID: NCT07295262
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2026-01-01
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ICG-Cisplatin Nanoprobe (NIR-II NanoM)
Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift\&NanICG), administered via superselective transarterial injection for tumor staining.
Fluorescence-guided Hepatectomy
Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.
Interventions
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ICG-Cisplatin Nanoprobe (NIR-II NanoM)
Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift\&NanICG), administered via superselective transarterial injection for tumor staining.
Fluorescence-guided Hepatectomy
Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.
Eligibility Criteria
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Inclusion Criteria
2. First diagnosis of Hepatocellular Carcinoma (HCC) (non-recurrent).
3. Single tumor with diameter ≤ 5 cm.
4. Assessed as resectable by more than 2 senior liver surgeons (experience \>10 years, \>500 hepatectomies).
5. No distant metastasis on preoperative chest CT and abdominal contrast-enhanced CT.
6. Child-Pugh Class A liver function.
7. Patient or legal guardian able to understand the study and sign informed consent.
Exclusion Criteria
2. Presence of portal vein, hepatic vein, or bile duct tumor thrombus.
3. History of other malignancies (except cured carcinoma in situ of cervix, basal cell carcinoma, or squamous cell skin carcinoma).
4. Evidence of residual lesion, recurrence, or metastasis during preoperative assessment; or postoperative pathology confirming lymph node metastasis or positive margins.
5. Moderate to severe ascites requiring therapeutic paracentesis/drainage, or Child-Pugh score \> 7 (except for small amount of ascites on imaging without clinical symptoms).
6. Uncontrolled or moderate/large amount of pleural effusion or pericardial effusion.
7. Severe cardiac, pulmonary, or renal dysfunction.
8. Ruptured HCC requiring emergency surgery.
9. Patient or family unable to understand the study conditions and objectives.
18 Years
75 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Jiwei Huang
Clinical Professor
Locations
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West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Jiwei Huang Professor
Role: primary
Other Identifiers
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JHuang20233
Identifier Type: -
Identifier Source: org_study_id