Combined Hepatocellular-cholangiocarcinomaNCT06849180
Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data
An observational study of Combined Hepatocellular-cholangiocarcinoma and Combined Hepatocellular Carcinoma and Cholangiocarcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
- What is being tested?
- Interventional therapies combined with or without systemic drugs
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 28 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for the planned retrospective analysis of this project is patients with pathologically confirmed mixed hepatocellular cholangiocarcinoma, based on the 2024 NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma [Version 2.2024]) and China's Primary Liver Cancer Diagnosis and Treatment Guidelines (2024) are defined as unresectable patients.
Who may be able to join
- age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
- patients with unresectable or metastatic CHC diagnosed on the basis of unresectable CHC who have received prior local therapy, systemic therapy, or a combination of both and have at least one measurable lesion (RECIST v1.1);
- survival time ≥ 3 months;
- ECOG PS 0-2;
- Child-Pugh A/B.
Who cannot join
- pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
- history of other malignant tumors within the past five years, unless these tumors have been completely treated and have been free of active disease for five years prior to the first dose and are at low risk of recurrence.
- fully treated carcinoma in situ with no evidence of disease.
- history of gastrointestinal bleeding or significant bleeding tendency (e.g., with known active ulcers, fecal occult blood, etc.) within the past six months that precludes inclusion in the study; gastroscopy is required if there is persistent fecal occult blood.
- substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
- other conditions that the investigator deems unsuitable for inclusion in the study. Inadequate information, such as incomplete data from laboratory tests, missing or poor quality imaging data, no prognostic information, etc., that the investigator considers unsuitable for inclusion in the study.
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
Zhongda Hospital
Nanjing, Jiangsu
Gao-Jun Teng, M.D, +86-02583272121, gjteng@vip.sina.com
About this study
Official title: Novel Subtypes and Treatment Strategies of Patients with Unresectable Mixed Hepatocellular Cholangiocarcinoma Based on Multimodal Data
This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.
Read the detailed description
This will be a multicenter observational study that will be conducted at several leading liver cancer treatment centers. The study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. Firstly, multi-modal data of different stages of disease were integrated by using cross-modal multi-course fusion technology to achieve efficient fusion of complex data. Secondly, by fine-tuning the large model, tasks such as CHC classification, prognosis inference and treatment plan recommendation are accurately completed, and potential information in the diagnosis and treatment process is mined.
- Conditions
- Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
- Being tested
- Interventional therapies combined with or without systemic drugs
- Keywords
- CHC, cHCC-ICC
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapies combined with or without systemic drugsCombination product
The study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. Firstly, multi-modal data of different stages of disease were integrated by using cross-modal multi-course fusion technology to achieve efficient fusion of complex data. Secondly, by fine-tuning the large model, tasks such as CHC classification, prognosis inference and treatment plan recommendation are accurately completed, and potential information in the diagnosis and treatment process is mined.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Measured: up to approximately 2 years
Secondary outcomes (9)
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Measured: up to approximately 2 years
ORR per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Measured: up to approximately 2 years
Duration of Response (DOR) per RESCIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
DOR per mRECIST
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
Measured: up to approximately 2 years
DCR per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
Measured: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start31 Dec 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Hepatocellular-cholangiocarcinomaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, M.D, Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849180
- Sponsor's protocol ID
- 2024040195
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Subtypes and Treatment Strategies of Patients with Unresectable Mixed Hepatocellular Cholangiocarcinoma Based on Multimodal Data
- ClinicalTrials.gov ID
- NCT06849180
- Acronym / sponsor ID
- 2024040195
- Conditions
- Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
- Keywords
- CHC, cHCC-ICC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Sun Yat-Sen University Cancer Center
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Feb 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 study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.
Detailed description
This will be a multicenter observational study that will be conducted at several leading liver cancer treatment centers. The study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. Firstly, multi-modal data of different stages of disease were integrated by using cross-modal multi-course fusion technology to achieve efficient fusion of complex data. Secondly, by fine-tuning the large model, tasks such as CHC classification, prognosis inference and treatment plan recommendation are accurately completed, and potential information in the diagnosis and treatment process is mined.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for the planned retrospective analysis of this project is patients with pathologically confirmed mixed hepatocellular cholangiocarcinoma, based on the 2024 NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma [Version 2.2024]) and China's Primary Liver Cancer Diagnosis and Treatment Guidelines (2024) are defined as unresectable patients.
Key inclusion criteria (5 listed)
- age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
- patients with unresectable or metastatic CHC diagnosed on the basis of unresectable CHC who have received prior local therapy, systemic therapy, or a combination of both and have at least one measurable lesion (RECIST v1.1);
- survival time ≥ 3 months;
- ECOG PS 0-2;
- Child-Pugh A/B.
Key exclusion criteria (6 listed)
- pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
- history of other malignant tumors within the past five years, unless these tumors have been completely treated and have been free of active disease for five years prior to the first dose and are at low risk of recurrence.
- fully treated carcinoma in situ with no evidence of disease.
- history of gastrointestinal bleeding or significant bleeding tendency (e.g., with known active ulcers, fecal occult blood, etc.) within the past six months that precludes inclusion in the study; gastroscopy is required if there is persistent fecal occult blood.
- substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
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 |
|---|---|---|
| Interventional therapies combined with or without systemic drugsThe study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. Firstly, multi-modal data of different stages of disease were integrated by using cross-modal multi-course fusion technology to achieve efficient fusion of complex data. Secondly, by fine-tuning the large model, tasks such as CHC classification, prognosis inference and treatment plan recommendation are accurately completed, and potential information in the diagnosis and treatment process is mined. | Combination product | – |
Primary outcome
Overall Survival(OS)
Time frame: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
9 secondary outcomes
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
Time frame: up to approximately 2 years
ORR per mRECIST
Time frame: up to approximately 2 years
Duration of Response (DOR) per RESCIST 1.1
Time frame: up to approximately 2 years
DOR per mRECIST
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
Time frame: up to approximately 2 years
DCR per mRECIST
Time frame: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
Time frame: up to approximately 2 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 27 Feb 2025.
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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.
Gao-Jun Teng, M.D principal investigator
Zhongda hospital, Southeast university, Nanjing, China
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 Combined Hepatocellular-cholangiocarcinoma and Combined Hepatocellular Carcinoma and Cholangiocarcinoma, run by Zhongda 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 5 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 27 Feb 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.
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 Gao-Jun Teng, M.D (+86-02583272121, gjteng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: up to approximately 2 years). 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 27 Feb 2025.