AI-Based Multimodal Integration for Tumor Microenvironment Analysis and Response Prediction in HCC Treated With TACE Plus Immunotherapy and Targeted Therapy (CHANCE2601)
7. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
1170
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhicheng Jin, MD
- Telefonnummer: +86-025-83272121
- E-post: jinzhic@foxmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total overlevelse (OS)
Tidsramme: opptil ca 2 år
|
OS er definert som tiden fra oppstart av kombinasjonsbehandling til død på grunn av en hvilken som helst årsak.
|
opptil ca 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
18. mai 2026
Primær fullføring (Antatt)
31. mai 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
7. mai 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Neoplasmer i leveren
- Karsinom
- Karsinom, hepatocellulært
- Algoritmer
- Matematiske konsepter
- Kunstig intelligens
Andre studie-ID-numre
- CHANCE2601
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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