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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer, Adult
• Intervention / Treatment: Drug: ICG-Cisplatin Nanoprobe (NIR-II NanoM); Procedure: Fluorescence-guided Hepatectomy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital
      • Contact: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-Year Recurrence-Free Survival (RFS)	Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause.	Up to 3 years post-surgery
Rate of Successful Fluorescence Staining	The proportion of participants with successful visualization of the tumor. Success is defined as the NIR-II nanoprobe showing clear fluorescence signals in the tumor tissue under the NIR-II imaging system during surgery, enabling the surgeon to distinguish tumor boundaries and liver segments for precise resection.	Intraoperative (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time interval from the date of surgical resection to the date of death from any cause. For participants who are lost to follow-up, the last known contact date will be used as the censorship time.	From date of surgery up to 3-5 years
Incidence of Perioperative Adverse Events and Complications	The number of participants experiencing adverse events related to the nanoprobe (e.g., allergic reactions, nephrotoxicity) or surgical complications (e.g., bleeding, infection, bile leakage, liver failure). Events will be monitored and recorded according to standard clinical practice.	From enrollment through 30 days post-surgery
Rate of Local Recurrence	The percentage of participants who develop tumor recurrence specifically in the original surgical area (resection margin or tumor bed), with or without an elevation in tumor markers.	From date of surgery up to 3 years
Rate of Distant Metastasis	The percentage of participants with metastasis detected in distant organs (e.g., lung, bone) or other liver segments. Metastasis is confirmed by CT, MRI, or nuclear scan without the mandatory need for pathological biopsy.	From date of surgery up to 3 years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: liver cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: JHuang20233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No