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

NCT06849180 | Recruiting

• 1 other identifier: 2024040195
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Combined Hepatocellular-cholangiocarcinoma; Combined Hepatocellular Carcinoma and Cholangiocarcinoma; Combined Hepatocellular and Cholangiocarcinoma

Keywords

CHC; cHCC-ICC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  up to approximately 2 years

• PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

  up to approximately 2 years

• Objective response rate(ORR) per RESCIST 1.1

  up to approximately 2 years

• ORR per mRECIST

  up to approximately 2 years

• Duration of Response (DOR) per RESCIST 1.1

  up to approximately 2 years

Interventions

Interventional therapies combined with or without systemic drugs COMBINATION_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.

Sponsors & Collaborators

• Zhongda Hospital: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Yunnan Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Sun Yet-Sen University Cancer Center: collaborator

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng, M.D

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, M.D

CONTACT

+86-02583272121; gjteng@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of interventional and Vascular Surgery Department

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: December 31, 2024
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)