Clinical trial · Observational
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers
NCT05278195CI-TRIAL-00057079CHANCEsubunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to id transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival(OS)
- timeFrame
- up to approximately 2 years
- description
- The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Secondary outcomes (4)
- measure
- Specificity
- timeFrame
- baseline
- description
- The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
- measure
- Sensitivity
- timeFrame
- baseline
- description
- The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval; 4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment; 5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment； 7\. Has repeated measurable intrahepatic lesions according to RECIST v1.1; Exclusion Criteria: 1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Unable to meet criteria of combination timeframe described above; 3. Missing follow-up data;
References
Publications (6)
- BACKGROUNDLlovet JM, Villanueva A, Marrero JA, Schwartz M, Meyer T, Galle PR, Lencioni R, Greten TF, Kudo M, Mandrekar SJ, Zhu AX, Finn RS, Roberts LR; AASLD Panel of Experts on Trial Design in HCC. Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference. Hepatology. 2021 Jan;73 Suppl 1:158-191. doi: 10.1002/hep.31327. Epub 2020 Sep 9. No abstract available. PMID 32430997
- BACKGROUNDLlovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3. PMID 33479224
- BACKGROUNDOchoa de Olza M, Navarro Rodrigo B, Zimmermann S, Coukos G. Turning up the heat on non-immunoreactive tumours: opportunities for clinical development. Lancet Oncol. 2020 Sep;21(9):e419-e430. doi: 10.1016/S1470-2045(20)30234-5. PMID 32888471
- BACKGROUNDPinato DJ, Murray SM, Forner A, Kaneko T, Fessas P, Toniutto P, Minguez B, Cacciato V, Avellini C, Diaz A, Boyton RJ, Altmann DM, Goldin RD, Akarca AU, Marafioti T, Mauri FA, Casagrande E, Grillo F, Giannini E, Bhoori S, Mazzaferro V. Trans-arterial chemoembolization as a loco-regional inducer of immunogenic cell death in hepatocellular carcinoma: implications for immunotherapy. J Immunother Cancer. 2021 Sep;9(9):e003311. doi: 10.1136/jitc-2021-003311. PMID 34593621
- DERIVEDChen Q, Lin LW, Jin ZC, Xiong B, Hu HT, Chen JJ, Zhou GH, Zhou HF, Ding R, Zhu XL, Huang M, Shi HB, Zhao ZW, Ji JS, Yang WZ, Xu GH, Xu AB, Hu ZC, Wang WD, Zhao C, Zhu HD, Teng GJ. The METAL Score for Early Stratification of Radiological Response and Survival in Hepatocellular Carcinoma Treated with TACE and Immunotherapy Combinations. Acad Radiol. 2026 Jan;33(1):47-58. doi: 10.1016/j.acra.2025.10.027. Epub 2025 Nov 4. PMID 41188158
- DERIVEDJin ZC, Zhou JW, Chen JJ, Ding R, Scheiner B, Wang SN, Li HL, Shen QX, Lu QY, Liu Y, Zhang WH, Luo B, Shi HB, Huang M, Wu YM, Yuan CW, Huang MS, Li JP, Wu JB, Zhu XL, Zhong BY, Zhou HF, Wang YQ, Gu SZ, Peng ZY, Zheng CS, Liu RB, Xu GH, Yang WZ, Xu AB, Liu DF, Qi X, Yeo YH, Zhu HD, Zhao Y, Pinato DJ, Ji F, Teng GJ. Longitudinal Body Composition Identifies Hepatocellular Carcinoma With Cachexia Following Combined Immunotherapy and Target Therapy (CHANCE2213). J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2705-2716. doi: 10.1002/jcsm.13615. Epub 2024 Nov 27.