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RecruitingNCT05047510Updated Aug 30, 2023

GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

An interventional study of Anti-GPC3-IRDye800CW in Hepatocellular Carcinoma, sponsored by Chinese Academy of Sciences. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Chinese Academy of Sciences · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma.

The main purposes of this study include:

① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore.

② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients who have been diagnosed with hepatocellular carcinoma.
  2. Planned to receive hepatectomy.
  3. Liver function Child-Pugh A/B.
  4. GPC-3 was validated highly expressed preoperatively.
  5. Aged 18 to 75, and the expected lifetime is longer than 6 months.
  6. Approved to sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Allergic to IRDye800.
  2. Enrolled in other trials in the past 3 months.
  3. Another malignant tumor was found.
  4. Undesirable function of heart, lung, kidney, or any other organs.
  5. Unable to tolerate a hepatectomy.
  6. The researchers considered inappropriate to be included.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Anti-GPC3-IRDye800CW Intraoperative Fluorescence

    The patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.

    Drug: Anti-GPC3-IRDye800CW

Interventions

  • DrugAnti-GPC3-IRDye800CW

    Drug Injection: Anti-GPC3-IRDye800CW

06

What researchers measure

Primary outcomes

  1. HCC lesions

    Numbers of intraoperatively detected hepatocellular carcinoma lesions.

    Time frame: During hepatocellular resection surgery.

07

Study locations

2 of 2 sites recruiting
  • Zhuhai People's Hospital
    Zhuhai, Guangdong, China
    Recruiting
  • The Affiliated Hospital of Southwest Medical University
    Luzhou, Sichuan, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05047510
Lead sponsor
Chinese Academy of Sciences
Responsible party
Zeyu Zhang, PHD (Principal Investigator, Chinese Academy of Sciences) — Principal investigator
First posted
Sep 17, 2021
Start date
Sep 10, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 30, 2023

Study contacts

Zeyu Zhang, Ph.D.
Contact
zhangzeyu@fingerpass.net.cn
86-18201082715

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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