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Recruiting NCT07295262

NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC

Early Phase I Interventional Liver Cancer, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICG-Cisplatin Nanoprobe (NIR-II NanoM), Fluorescence-guided Hepatectomy.
Who it may be relevant to
Registry conditions: Liver Cancer, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection

Overview

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.

Interventions

  • Drug 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.
  • Procedure Fluorescence-guided Hepatectomy
    Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.

Primary outcome measures

  • 3-Year Recurrence-Free Survival (RFS) [Time frame: Up to 3 years post-surgery]
  • Rate of Successful Fluorescence Staining [Time frame: Intraoperative (Day 0)]
Secondary outcome measures (4)
  • Overall Survival (OS) [Time frame: From date of surgery up to 3-5 years]
  • Incidence of Perioperative Adverse Events and Complications [Time frame: From enrollment through 30 days post-surgery]
  • Rate of Local Recurrence [Time frame: From date of surgery up to 3 years]
  • Rate of Distant Metastasis [Time frame: From date of surgery up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital — Chengdu

Identifiers

NCT: NCT07295262 · JHuang20233

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗