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

Early Phase 1RecruitingNCT07295262

West China Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cancer, Adult

Interventions

ICG-Cisplatin Nanoprobe (NIR-II NanoM)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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.