Liver Cancer, AdultEarly Phase 1NCT07295262
NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
A Early Phase 1 study testing ICG-Cisplatin Nanoprobe (NIR-II NanoM) and Fluorescence-guided Hepatectomy in people with Liver Cancer, Adult, run by West China Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Adult
- What is being tested?
- ICG-Cisplatin Nanoprobe (NIR-II NanoM) and Fluorescence-guided Hepatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- Severe cardiac, pulmonary, or renal dysfunction.
- Ruptured HCC requiring emergency surgery.
- Patient or family unable to understand the study conditions and objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Jiwei Huang Professor, 18980606725, huangjiwei@wchscu.cn
About this study
Official title: ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection
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.
- Conditions
- Liver Cancer, Adult
- Being tested
- ICG-Cisplatin Nanoprobe (NIR-II NanoM), Fluorescence-guided Hepatectomy
- Keywords
- liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-Cisplatin Nanoprobe (NIR-II NanoM)Drug
Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol (Shift\&NanICG), administered via superselective transarterial injection for tumor staining.
Fluorescence-guided HepatectomyProcedure or surgery
Laparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: NIR-II NanoM Group | Experimental | Patients receive transarterial embolization (TAE) with ICG-Cisplatin self-assembled nanoprobes (NIR-II NanoM) mixed with lipiodol, followed by fluorescence-guided laparoscopic anatomic hepatectomy. Receives: Drug: ICG-Cisplatin Nanoprobe (NIR-II NanoM); Procedure: Fluorescence-guided Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Recurrence-Free Survival (RFS)
Calculated from the date of surgery to the date of first documented recurrence (local or distant) or death from any cause.
Measured: Up to 3 years post-surgery
Rate of Successful Fluorescence Staining
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.
Measured: Intraoperative (Day 0)
Secondary outcomes (4)
Overall Survival (OS)
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.
Measured: From date of surgery up to 3-5 years
Incidence of Perioperative Adverse Events and Complications
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.
Measured: From enrollment through 30 days post-surgery
Rate of Local Recurrence
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.
Measured: From date of surgery up to 3 years
Rate of Distant Metastasis
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.
Measured: From date of surgery up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwei Huang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295262
- Sponsor's protocol ID
- JHuang20233
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG-Cisplatin Self-Assembled Nanoprobes for Near-Infrared-Il Fluorescence Imaging-Guided Liver Resection
- ClinicalTrials.gov ID
- NCT07295262
- Acronym / sponsor ID
- JHuang20233
- Conditions
- Liver Cancer, Adult
- Keywords
- liver cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: NIR-II NanoM Group | Experimental | Drug: ICG-Cisplatin Nanoprobe (NIR-II NanoM), Procedure: Fluorescence-guided HepatectomyPatients receive transarterial embolization (TAE) with ICG-Cisplatin self-assembled nanoprobes (NIR-II NanoM) mixed with lipiodol, followed by fluorescence-guided laparoscopic anatomic hepatectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Moderate to severe ascites requiring therapeutic paracentesis/drainage, or Child-Pugh score > 7 (except for small amount of ascites on imaging without clinical symptoms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-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. | Drug | Experimental: NIR-II NanoM Group |
| Fluorescence-guided HepatectomyLaparoscopic anatomic hepatectomy guided by Near-Infrared II (NIR-II) fluorescence imaging system to visualize tumor boundaries. | Procedure or surgery | Experimental: NIR-II NanoM Group |
Primary outcome
3-Year Recurrence-Free Survival (RFS)
Time frame: 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
Time frame: 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.
4 secondary outcomes
Overall Survival (OS)
Time frame: From date of surgery up to 3-5 years
Incidence of Perioperative Adverse Events and Complications
Time frame: From enrollment through 30 days post-surgery
Rate of Local Recurrence
Time frame: From date of surgery up to 3 years
Rate of Distant Metastasis
Time frame: From date of surgery up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ICG-Cisplatin Nanoprobe (NIR-II NanoM) and Fluorescence-guided Hepatectomy in people with Liver Cancer, Adult, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Huang Professor (18980606725, huangjiwei@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Recurrence-Free Survival (RFS) (time frame: Up to 3 years post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.