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Recruiting NCT06849180

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

— Observational Combined Hepatocellular-cholangiocarcinoma Combined Hepatocellular Carcinoma and Cholangiocarcinoma Combined Hepatocellular and Cholangiocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interventional therapies combined with or without systemic drugs.
Who it may be relevant to
Registry conditions: Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Combination product Interventional therapies combined with or without systemic drugs
    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. F

Primary outcome measures

  • Overall Survival(OS) [Time frame: up to approximately 2 years]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Zhongda Hospital — Nanjing

Identifiers

NCT: NCT06849180 · 2024040195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗