NCT07295262RecruitingEarly phase 1
NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- West China Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07295262
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 1 Jan 2026 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ruptured HCC requiring emergency surgery.
Other illness
- History of other malignancies (except cured carcinoma in situ of cervix, basal cell carcinoma, or squamous cell skin carcinoma).
- Severe cardiac, pulmonary, or renal dysfunction.
- Patient or family unable to understand the study conditions and objectives.
Other
- Postoperative pathology confirms cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma.
- Presence of portal vein, hepatic vein, or bile duct tumor thrombus.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.