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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Jiwei Huang Professor
• Email: huangjiwei@wchscu.cn
• Phone: 18980606725

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.