Liver Cancer, Adult
Conditions
Keywords
liver cancer
Brief summary
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.
Interventions
DRUGICG-Cisplatin Nanoprobe (NIR-II NanoM)
Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift&NanICG), administered via superselective transarterial injection for tumor staining.
PROCEDUREFluorescence-guided Hepatectomy
Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Recurrence-Free Survival (RFS) | Up to 3 years post-surgery | Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause. |
| Rate of Successful Fluorescence Staining | Intraoperative (Day 0) | The proportion of participants with successful visualization of the tumor. Success is defined as the NIR-II nanoprobe showing clear fluorescence signals in the tumor tissue under the NIR-II imaging system during surgery, enabling the surgeon to distinguish tumor boundaries and liver segments for precise resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Local Recurrence | From date of surgery up to 3 years | The percentage of participants who develop tumor recurrence specifically in the original surgical area (resection margin or tumor bed), with or without an elevation in tumor markers. |
| Overall Survival (OS) | From date of surgery up to 3-5 years | OS is defined as the time interval from the date of surgical resection to the date of death from any cause. For participants who are lost to follow-up, the last known contact date will be used as the censorship time. |
| Incidence of Perioperative Adverse Events and Complications | From enrollment through 30 days post-surgery | The number of participants experiencing adverse events related to the nanoprobe (e.g., allergic reactions, nephrotoxicity) or surgical complications (e.g., bleeding, infection, bile leakage, liver failure). Events will be monitored and recorded according to standard clinical practice. |
| Rate of Distant Metastasis | From date of surgery up to 3 years | The percentage of participants with metastasis detected in distant organs (e.g., lung, bone) or other liver segments. Metastasis is confirmed by CT, MRI, or nuclear scan without the mandatory need for pathological biopsy. |
Countries
China
Contacts
Primary ContactJiwei Huang Professor
Outcome results
None listed