Hepatocellular Carcinoma Stage IIINCT06559761
Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
An observational study of Hepatocellular Carcinoma Stage III, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Stage III
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2029
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy
Who may be able to join
- According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
- The initial treatment is curative-intent hepatectomy.
- There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
- Age 18-80 years old.
Who cannot join
- Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.
Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.
By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.
- Conditions
- Hepatocellular Carcinoma Stage III
- Being tested
- Hepatectomy
- Keywords
- Hepatocellular Carcinoma, Prognosis, Imaging, Gross classification
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
According to guideline recommended procedure of hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| TYPE I | Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope Receives: Procedure: Hepatectomy | |
| TYPE II | Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points Receives: Procedure: Hepatectomy | |
| TYPE III | Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules Receives: Procedure: Hepatectomy | |
| TYPE IV | Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Disease-free survival
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier
Measured: through study completion, an average of 1 year
Imaging features
MRI or ultrasound Imaging features of the four types
Measured: through study completion, an average of 1 year
Quantification of immune cells of the resected liver tumour
Quantification of immune cells of the resected liver tumour using HE staining and immunohistological staining to assess molecular marker and cell infiltration in tumor and liver parenchyma
Measured: through study completion, an average of 1 year
mRNA sequencing data of the resected liver tumour and peritumor parenchyma
mRNA sequencing data of the resected liver tumour and peritumor parenchyma specimen to assess the gene enrichment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Stage IIIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559761
- Sponsor's protocol ID
- S2024-423
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
- ClinicalTrials.gov ID
- NCT06559761
- Acronym / sponsor ID
- S2024-423
- Conditions
- Hepatocellular Carcinoma Stage III
- Keywords
- Hepatocellular Carcinoma, Prognosis, Imaging, Gross classification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Aug 2024 (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.
Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.
Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.
By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TYPE I | – | Procedure: HepatectomyGross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope |
| TYPE II | – | Procedure: HepatectomyGross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points |
| TYPE III | – | Procedure: HepatectomyGross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules |
| TYPE IV | – | Procedure: HepatectomyGross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy
Key inclusion criteria (4 listed)
- According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
- The initial treatment is curative-intent hepatectomy.
- There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
- Age 18-80 years old.
Key exclusion criteria (1 listed)
- Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.
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 |
|---|---|---|
| HepatectomyAccording to guideline recommended procedure of hepatectomy | Procedure or surgery | TYPE I, TYPE II, TYPE III, TYPE IV |
Primary outcome
Overall survival
Time frame: through study completion, an average of 1 year
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
4 secondary outcomes
Disease-free survival
Time frame: through study completion, an average of 1 year
Imaging features
Time frame: through study completion, an average of 1 year
Quantification of immune cells of the resected liver tumour
Time frame: through study completion, an average of 1 year
mRNA sequencing data of the resected liver tumour and peritumor parenchyma
Time frame: through study completion, an average of 1 year
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 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Stage III, run by Chinese PLA General 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 4 inclusion and 1 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 Aug 2024. 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.
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 Chuan Pang (18910527022, pcpang117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: through study completion, an average of 1 year). 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 Aug 2024.