Actively Recruiting
ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-II Fluorescence Imaging-Guided Liver Resection
Led by West China Hospital · Updated on 2025-12-19
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method to guide surgery for patients with Hepatocellular Carcinoma (HCC), a type of liver cancer. This early-phase study focuses on the safety and feasibility of using a novel nanoprobe made from Indocyanine Green and Cisplatin, called NIR-II NanoM, to help surgeons see tumor boundaries more clearly during operation. The goal is to improve precision in liver cancer surgery and study how well this imaging technique works. Participants will receive an injection of the nanoprobe mixed with lipiodol directly into the liver artery before surgery. After this, patients will undergo laparoscopic anatomic hepatectomy, where surgeons use a Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor edges and liver segments for a more precise removal. This single-arm study involves this one experimental treatment approach. During the study, patients will be closely monitored before, during, and after surgery. Researchers will measure how effectively the nanoprobe stains the tumor during surgery and track patients for up to three years to observe recurrence-free survival. They will also assess overall survival, adverse events, complications, and rates of local recurrence or distant metastasis. Follow-up includes regular imaging and health assessments to ensure safety and track long-term outcomes.
CONDITIONS
Brief Title
NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- First diagnosis of Hepatocellular Carcinoma (HCC), no recurrence
- Single tumor with diameter 5 cm or less
- Tumor assessed as resectable by more than two senior liver surgeons with extensive experience
- No distant metastasis on chest CT and abdominal contrast-enhanced CT before surgery
- Child-Pugh Class A liver function
- Patient or legal guardian able to understand the study and provide informed consent
You will not qualify if you...
- Postoperative pathology confirming cholangiocarcinoma, sarcomatoid HCC, combined HCC-ICC, or fibrolamellar carcinoma
- Presence of tumor thrombus in portal vein, hepatic vein, or bile duct
- 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 before surgery or positive lymph nodes or margins after surgery
- Moderate to severe ascites requiring treatment or Child-Pugh score above 7 (except small asymptomatic ascites)
- Uncontrolled or moderate/large pleural or pericardial effusion
- Severe heart, lung, or kidney dysfunction
- Ruptured HCC requiring emergency surgery
- Patient or family unable to understand study conditions and goals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants receive transarterial embolization with ICG-Cisplatin nanoprobes for tumor staining, followed by fluorescence-guided laparoscopic anatomic hepatectomy.
1 treatment visit and surgery day
Duration - Up to 5 years post-surgery
Participants are monitored for recurrence, survival, and any perioperative adverse events for up to 3 to 5 years after surgery.
Periodic follow-up visits for up to 5 years
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jiwei Huang Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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