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
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
Treatments tested in this trial
- ICG-Cisplatin Nanoprobe (NIR-II NanoM)
- Fluorescence-guided Hepatectomy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov