Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence-guided Hepatectomy | Procedure | — | UNRESOLVED |
| ICG-Cisplatin Nanoprobe (NIR-II NanoM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: NIR-II NanoM Group
- description
- Patients receive transarterial embolization (TAE) with ICG-Cisplatin self-assembled nanoprobes (NIR-II NanoM) mixed with lipiodol, followed by fluorescence-guided laparoscopic anatomic hepatectomy.
- interventionNames
- Drug: ICG-Cisplatin Nanoprobe (NIR-II NanoM)
- Procedure: Fluorescence-guided Hepatectomy
Primary outcomes (2)
- measure
- 3-Year Recurrence-Free Survival (RFS)
- timeFrame
- Up to 3 years post-surgery
- description
- Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause.
- measure
- Rate of Successful Fluorescence Staining
- timeFrame
- Intraoperative (Day 0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years. 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: 1. Postoperative pathology confirms cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma. 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.
References
Publications (0)
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