Health TrialsbyHealthPanel

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

ConditionLiver Cancer, Adult
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental: NIR-II NanoM GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 3 years post-surgery
2

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.

Time frame
Intraoperative (Day 0)

Secondary outcomes

1

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.

Time frame
From date of surgery up to 3-5 years
2

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.

Time frame
From enrollment through 30 days post-surgery
3

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.

Time frame
From date of surgery up to 3 years
4

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.

Time frame
From date of surgery up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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