NCT07295262 NIR-II Fluorescence-Guided Hepatectomy Using ICG-Cisplatin Nanoprobes for HCC
| NCT ID | NCT07295262 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | West China Hospital |
| Condition | Liver Cancer, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-01-01 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07295262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Cancer, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07295262 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07295262 currently recruiting?
Yes, NCT07295262 is actively recruiting participants. Contact the research team at huangjiwei@wchscu.cn for enrollment information.
Where is the NCT07295262 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07295262 clinical trial?
NCT07295262 is sponsored by West China Hospital. The trial plans to enroll 30 participants.
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