Clinical trial · Observational
Survival Analysis: TACE vs. Combination Therapy in HCC
Survival Analysis of TACE Monotherapy vs. Combination Therapy in BCLC B and C Stage Hepatocellular Carcinoma: A Retrospective Cohort Study
NCT06261138CI-TRIAL-00074060completedClinicalTrials.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)
This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systemic treatment | Other | — | UNRESOLVED |
| Transarterial chemoembolization | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TACE group
- description
- Patients included in the study underwent either conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) procedures performed by experienced interventional radiologists, taking into account tumor burden, patient tolerance, and individual preferences.
- interventionNames
- Drug: Transarterial chemoembolization
- label
- Combination group
- description
- Systemic treatment commenced within one month after the initial TACE procedure, depending on the proper liver function. Anti-angiogenic agents involved in this study mainly comprised multikinase tyrosine kinase inhibitors. ICIs included therapies targeting programmed cell death protein 1 and its ligands.
- interventionNames
- Drug: Transarterial chemoembolization
- Other: Systemic treatment
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) per mRECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Both sexes, aged 18-75 years old; (2) HCC was clinically or pathologically diagnosed according to the American Association for Liver Diseases (ASSLD) criteria; (3) One or more tumor lesions could be measured according to modified response evaluation criteria in solid tumors (mRECIST) on enhanced CT or MRI; (4) For patients with Barcelona Clinic Liver Cancer (BCLC) stage B or stage C hepatocellular carcinoma (HCC) in Barcelona, and who are not suitable for surgical resection, it is recommended to undergo transarterial chemoembolization (TACE) or combination therapy involving TACE as the initial treatment; (5)Child-Pugh grade A or B, no hydrothorax, ascites and hepatic encephalopathy requiring treatment; (6) Eastern Cooperative Oncology Group performance status (ECOG-PS) score 0-1; (7) Have enough liver and kidney function in patients with appropriate laboratory indicators: hemoglobin concentration (HGB) hemoglobin, acuity 9.0 g/dl, neutrophils acuity 1500 cells/mm3, PLT 50 \* 109 / L, or serum propagated 28 g/L, or TBIL\< 50umol/L, ALT, AST\< 5 times the upper limit of normal, Bun, Cr\< 1.5 times the upper limit of normal, INR\< 1.7 or PT prolongation \< 4s Exclusion Criteria: 1. Other malignant tumors outside HCC, such as liver metastasis of colon cancer; (2) Child-Pugh grade C; (3) Contraindications to TACE, lenvatinib or tislelizumab; (4) Any active autoimmune diseases or autoimmune disease, thyroid function hyperfunction or decline, which is to be bronchodilator treatment of asthma; (5) There are serious complications, including serious heart, lung, kidney, blood coagulation dysfunction; Important cardiovascular diseases such as heart disease of the definition of New York heart association level 3 or higher, instability during the treatment of myocardial infarction, arrhythmia, unstable angina, etc; (6) Past history of patients with idiopathic pulmonary fibrosis , Machine pneumonia (e.g., occlusive bronchiolitis), drug pneumonia, idiopathic pneumonia or chest CT screening to find evidence for an active pneumonia; (7) Patients with previous allogeneic stem cell or solid organ transplantation, including patients after liver transplantation; (8) Clinical data absence or incomplete information.
References
Publications (0)
Data not yet available
No reference posted for this study.