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

NCT07295262 | Recruiting Early Phase 1

• 1 other identifier: JHuang20233
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Cancer, Adult

Keywords

liver cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall Survival (OS)

  From date of surgery up to 3-5 years

• Incidence of Perioperative Adverse Events and Complications

  From enrollment through 30 days post-surgery

• Rate of Local Recurrence

  From date of surgery up to 3 years

• Rate of Distant Metastasis

  From date of surgery up to 3 years

Study Arms (1)

Experimental: NIR-II NanoM Group

EXPERIMENTAL

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); Procedure: Fluorescence-guided Hepatectomy

Interventions

Fluorescence-guided Hepatectomy PROCEDURE

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

Experimental: NIR-II NanoM Group

ICG-Cisplatin Nanoprobe (NIR-II NanoM) DRUG

Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift\&NanICG), administered via superselective transarterial injection for tumor staining.

Experimental: NIR-II NanoM Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jiwei Huang Professor

CONTACT

18980606725; huangjiwei@wchscu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)