NIR‑II fluorescence guidance with ICG‑cisplatin nanoprobes for liver tumor resection

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

This study tries a new ICG‑cisplatin nanoprobe injected through the liver artery to help surgeons see and remove single small hepatocellular carcinomas during laparoscopic anatomic hepatectomy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07295262 on ClinicalTrials.gov

What this trial studies

This prospective, single-arm early-phase 1 trial tests a self‑assembled ICG‑cisplatin nanoprobe (NIR‑II NanoM) delivered via transarterial injection mixed with lipiodol prior to surgery. During the planned laparoscopic anatomic hepatectomy, surgeons will use a Near‑Infrared II imaging system to visualize tumor boundaries and liver segments for more precise resection. Eligible patients are adults with a first diagnosis of hepatocellular carcinoma, a single tumor ≤5 cm, Child‑Pugh A liver function, and no distant metastasis. The primary aims are to determine the feasibility and safety of using the nanoprobe to guide intraoperative fluorescence imaging.

Who should consider this trial

Good fit: Adults 18–75 years with a first diagnosis of resectable hepatocellular carcinoma consisting of a single tumor ≤5 cm, Child‑Pugh A liver function, no distant metastasis, and deemed resectable by experienced liver surgeons.

Not a fit: Patients with multifocal or recurrent disease, tumors >5 cm, vascular or bile duct tumor thrombus, poor liver function (Child‑Pugh B/C), distant metastases, or excluded histologic subtypes are unlikely to benefit.

Why it matters

Potential benefit: If successful, the approach could improve intraoperative tumor visualization, enable more precise resections with clearer margins, and spare healthy liver tissue.

How similar studies have performed: ICG‑based and NIR‑II fluorescence guidance have shown promise in preclinical and early clinical studies for tumor visualization, but the ICG‑cisplatin self‑assembled nanoprobe is a novel formulation with limited human data so far.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Jiwei Huang Professor

Conditions Liver Cancer, Adult; liver cancer