Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT07295262

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

Led by West China Hospital · Updated on 2025-12-19

30

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • First diagnosis of Hepatocellular Carcinoma (HCC) without recurrence
  • Single tumor with diameter 5 cm or less
  • Tumor assessed as safely resectable by at least two senior liver surgeons
  • No distant metastasis shown on chest CT and abdominal contrast-enhanced CT
  • Child-Pugh Class A liver function
  • Patient or legal guardian can understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Postoperative pathology shows cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma
  • Presence of tumor thrombus in portal vein, hepatic vein, or bile duct
  • History of other cancers except cured carcinoma in situ of cervix or certain skin cancers
  • Evidence of residual tumor, recurrence, metastasis, lymph node metastasis, or positive surgical margins
  • Moderate to severe ascites needing therapeutic drainage or Child-Pugh score over 7 except minor ascites without symptoms
  • Uncontrolled or moderate/large pleural or pericardial effusion
  • Severe heart, lung, or kidney dysfunction
  • Ruptured liver cancer requiring emergency surgery
  • Patient or family unable to understand study conditions and objectives

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

J

Jiwei Huang Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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