Hepatocellular CarcinomaNCT05047510
GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma
A study testing Anti-GPC3-IRDye800CW in people with Hepatocellular Carcinoma, run by Chinese Academy of Sciences at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Anti-GPC3-IRDye800CW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 10 Sep 2021to 31 Dec 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with hepatocellular carcinoma.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- GPC-3 was validated highly expressed preoperatively.
- Aged 18 to 75, and the expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
Who cannot join
- Allergic to IRDye800.
- Enrolled in other trials in the past 3 months.
- Another malignant tumor was found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
- The researchers considered inappropriate to be included.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
- Recruiting
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Official title: An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anti-GPC3-IRDye800CW
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-GPC3-IRDye800CWDrug
Drug Injection: Anti-GPC3-IRDye800CW
| Study group | Role | What they receive |
|---|---|---|
| Anti-GPC3-IRDye800CW Intraoperative Fluorescence | Experimental | 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. Receives: Drug: Anti-GPC3-IRDye800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC lesions
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
Measured: During hepatocellular resection surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start10 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeyu Zhang, PHD, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047510
- Sponsor's protocol ID
- Chinese Academy of Sciences
- Status last verified
- Aug 2023
- First submitted
- 8 Sep 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05047510
- Acronym / sponsor ID
- Chinese Academy of Sciences
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Sep 2021 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-GPC3-IRDye800CW Intraoperative Fluorescence | Experimental | Drug: Anti-GPC3-IRDye800CWThe patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have been diagnosed with hepatocellular carcinoma.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- GPC-3 was validated highly expressed preoperatively.
- Aged 18 to 75, and the expected lifetime is longer than 6 months.
Key exclusion criteria (6 listed)
- Allergic to IRDye800.
- Enrolled in other trials in the past 3 months.
- Another malignant tumor was found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
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 |
|---|---|---|
| Anti-GPC3-IRDye800CWDrug Injection: Anti-GPC3-IRDye800CW | Drug | Anti-GPC3-IRDye800CW Intraoperative Fluorescence |
Primary outcome
HCC lesions
Time frame: During hepatocellular resection surgery.
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
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 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-GPC3-IRDye800CW in people with Hepatocellular Carcinoma, run by Chinese Academy of Sciences at 2 sites 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 6 inclusion and 6 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Zeyu Zhang, Ph.D. (86-18201082715, zhangzeyu@fingerpass.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC lesions (time frame: During hepatocellular resection surgery.). 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 30 Aug 2023.