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NCT Number: NCT07295262

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

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.

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Key information

Conditions

Liver Cancer, Adult Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Jiwei Huang Professor

CONTACT

[email protected]

18980606725

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Fluorescence-guided Hepatectomy

Procedure

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

Primary outcomes

  1. 3-Year Recurrence-Free Survival (RFS)

    Time frame: Up to 3 years post-surgery

    Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause.

  2. Rate of Successful Fluorescence Staining

    Time frame: Intraoperative (Day 0)

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From date of surgery up to 3-5 years

    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.

  2. Incidence of Perioperative Adverse Events and Complications

    Time frame: From enrollment through 30 days post-surgery

    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.

  3. Rate of Local Recurrence

    Time frame: From date of surgery up to 3 years

    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.

  4. Rate of Distant Metastasis

    Time frame: From date of surgery up to 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang Professor

CONTACT

[email protected]

18980606725

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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