AI-Based Multimodal Integration for Tumor Microenvironment Analysis and Response Prediction in HCC Treated With TACE Plus Immunotherapy and Targeted Therapy (CHANCE2601)
7. maj 2026 opdateret af: Gao-jun Teng
Artificial Intelligence-Based Multimodal Data Integration for Tumor Microenvironment Analysis and Response Prediction in Hepatocellular Carcinoma Patients Undergoing TACE Combined With Immunotherapy and Targeted Therapy
This study aims to prospectively validate a retrospective cohort-derived AI-based multimodal model and explore tumor heterogeneity and the immune microenvironment to guide TACE combined with immunotherapy and targeted therapy in HCC.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will integrate a retrospective cohort with a prospective observational cohort.
Multimodal data will be collected in the prospective cohort to validate the AI-based imaging model developed from the retrospective cohort.
In addition, advanced multi-omics technologies will be incorporated to characterize tumor heterogeneity and the immune microenvironment, thereby supporting early and precise guidance for TACE combined with immunotherapy and targeted therapy in HCC.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1170
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhicheng Jin, MD
- Telefonnummer: +86-025-83272121
- E-mail: jinzhic@foxmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
In the retrospective cohort, patients with HCC who received TACE combined with immunotherapy and targeted therapy, as well as other treatment modalities, will be retrospectively included.
Multimodal data from this cohort will be used to develop and train the AI-based model.
In the prospective cohort, patients with HCC who receive TACE combined with immunotherapy and targeted therapy will be prospectively enrolled.
Multimodal data, including clinical, imaging, and biospecimen-related data when available, will be collected to validate the AI-based multimodal model.
Beskrivelse
Retrospective Study Cohort 1.1 Inclusion Criteria Age ≥18 years; Patients with hepatocellular carcinoma confirmed by histopathology or clinical diagnosis; At least one intrahepatic lesion that is repeatedly measurable according to RECIST v1.1.
1.2 Exclusion Criteria Known sarcomatoid hepatocellular carcinoma or fibrolamellar hepatocellular carcinoma; Presence of other active malignancies within the past 5 years or concurrent active malignancies other than hepatocellular carcinoma; Missing preoperative imaging examinations, including CT or MRI, or poor image quality; Missing key baseline clinical data; Loss to follow-up after treatment.
- Prospective Study Cohort 2.1 Inclusion Criteria Age ≥18 years; Patients with hepatocellular carcinoma confirmed by histopathology or clinical diagnosis; Scheduled to receive first-line TACE combined with immunotherapy and targeted therapy; At least one intrahepatic lesion that is repeatedly measurable according to RECIST v1.1; Expected survival of more than 3 months. 2.2 Exclusion Criteria Known sarcomatoid hepatocellular carcinoma or fibrolamellar hepatocellular carcinoma; Presence of other active malignancies within the past 5 years or concurrent active malignancies other than hepatocellular carcinoma; Other factors that, in the investigator's judgment, make the patient unsuitable for participation in this study; Severe allergy to iodinated contrast agents that preclude imaging examinations or TACE treatment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Retrospective cohort
Patients with hepatocellular carcinoma who received TACE combined with immunotherapy and targeted therapy, as well as other treatment modalities, will be retrospectively included.
Multimodal data from this cohort will be used to develop and train the AI-based model.
|
Investigators utilize a AI-based supportive system to predict clinical outcomes for patients with hepatocellular carcinoma who received TACE combined with immunotherapy and targeted therapy
|
|
Prospective cohort
Patients with hepatocellular carcinoma who receive TACE combined with immunotherapy and targeted therapy will be prospectively enrolled.
Multimodal data, including clinical, imaging, and biospecimen-related data when available, will be collected to validate the AI-based multimodal model.
|
Investigators utilize a AI-based supportive system to predict clinical outcomes for patients with hepatocellular carcinoma who received TACE combined with immunotherapy and targeted therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prediction Performance of the AI Model
Tidsramme: From enrollment to approximately 2 years
|
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves o f the AI model in predicting the clinical outcomes in patients receiving TACE combined with immunotherapy and targeted therapy.
|
From enrollment to approximately 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse (OS)
Tidsramme: op til cirka 2 år
|
OS er defineret som tiden fra påbegyndelse af enhver kombinationsbehandling til død på grund af en hvilken som helst årsag.
|
op til cirka 2 år
|
|
Objective response rate(ORR)
Tidsramme: up to approximately 2 years
|
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1 or per mRECIST.
|
up to approximately 2 years
|
|
Progression free survival(PFS)
Tidsramme: up to approximately 2 years
|
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 mRECIST) or death due to any cause, whichever occurs first.
|
up to approximately 2 years
|
|
Other prediction performance of the model
Tidsramme: From enrollment to approximately 2 years
|
Evaluation of the accuracy, sensitivity, and specificity of the prediction model in clinical application
|
From enrollment to approximately 2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Zhong BY, Fan W, Guan JJ, Peng Z, Jia Z, Jin H, Jin ZC, Chen JJ, Zhu HD, Teng GJ. Combination locoregional and systemic therapies in hepatocellular carcinoma. Lancet Gastroenterol Hepatol. 2025 Apr;10(4):369-386. doi: 10.1016/S2468-1253(24)00247-4. Epub 2025 Feb 21.
- Jin ZC, Wei J, Xiao YD, Si A, Chen JJ, Zhu XL, Li JZ, Nie F, Ding R, Zhou HF, Ding W, Zhong BY, Xie Y, Hu HT, Yin GW, Ji JS, Zhang WH, Shi HB, Wu JB, Xu GH, Yuan CW, Yang WZ, Liu RB, Wu YM, Zheng CS, Xu AB, Huang MS, Li JP, Chen L, Wen SW, Wang YQ, Gu SZ, Li D, Wang D, Zhou GH, Wang WD, Peng Z, Wang X, Zhu HD, Tian J, Teng GJ. Decoding tumor heterogeneity with imaging biomarkers predicts response to TACE plus immunotherapy and targeted therapy in HCC (CHANCE2204). Hepatology. 2025 Nov 10. doi: 10.1097/HEP.0000000000001593. Online ahead of print.
- Vithayathil M, Koku D, Campani C, Nault JC, Sutter O, Ganne-Carrie N, Aboagye EO, Sharma R. Machine learning based radiomic models outperform clinical biomarkers in predicting outcomes after immunotherapy for hepatocellular carcinoma. J Hepatol. 2025 Oct;83(4):959-970. doi: 10.1016/j.jhep.2025.04.017. Epub 2025 Apr 17.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
18. maj 2026
Primær færdiggørelse (Anslået)
31. maj 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
7. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHANCE2601
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