Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data

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.

Study Overview

• Status: Recruiting
• Conditions: Combined Hepatocellular Carcinoma and Cholangiocarcinoma; Combined Hepatocellular and Cholangiocarcinoma; Combined Hepatocellular-cholangiocarcinoma
• Intervention / Treatment: Combination product: Interventional therapies combined with or without systemic drugs

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 Type: Observational
• Enrollment (Estimated): 198

Contacts and Locations

• Study Contact: Name: Gao-Jun Teng, M.D; Phone Number: +86-02583272121; Email: gjteng@vip.sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda hospital
      • Contact: Gao-Jun Teng, M.D; Phone Number: +86-02583272121; Email: gjteng@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
2. 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);
3. survival time ≥ 3 months;
4. ECOG PS 0-2;
5. Child-Pugh A/B.

Exclusion Criteria:

1. pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
2. 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.
3. fully treated carcinoma in situ with no evidence of disease.
4. 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.
5. substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
6. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.	up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	up to approximately 2 years

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Collaborators: Zhejiang Cancer Hospital; Shanghai Zhongshan Hospital; The First Affiliated Hospital of Zhengzhou University; Jiangsu Cancer Institute & Hospital; Eastern Hepatobiliary Surgery Hospital; Yunnan Cancer Hospital; Sun Yet-Sen University Cancer Center
• Investigators: Principal Investigator: Gao-jun Teng, M.D, Zhongda hospital, Southeast university, Nanjing, China

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: CHC; cHCC-ICC
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma
• Other Study ID Numbers: 2024040195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No