Clinical trial · Observational
TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.
Transcatheter Arterial Chemoembolization Combined With ICIs Plus MTT After Irradiation Stent Placement in HCC With Main PVTT: a Multicenter Propensity Score Matching Study
- 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)
Hepatocellular carcinoma (HCC) patients with Vp4 \[main trunk\] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 PVTT.
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
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 (9)
- measure
- Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- timeFrame
- up to approximately 2 years
- description
- 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 death due to any cause, whichever occurs first.
- measure
- PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- timeFrame
- up to approximately 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥18 years old; (2) diagnosis of HCC is confirmed through histological or cytological analysis, as well as clinical features; (3) histologically confirmed or imaging-diagnosed PVTT extending to the main portal vein (Vp4); (4) including at least one measurable intrahepatic lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (5) Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; (6) patients received first-line treatment with either ICIs-MTT or an ISP-containing quadruple combination within eight weeks (In the ICIs-MTT group, MTT was administered alongside ICIs. In the ISP-containing quadruple, TIT and ICIs-MTT were given after stent placement and portal vein recanalization, either simultaneously or within eight weeks before or after the ICIs-MTT therapy). Exclusion Criteria: 1. patients with extrahepatic metastases; (2) a history of or concurrent malignancies; (3) patients underwent prior systemic treatments or locoregional therapies, including surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection, and cryoablation, within three months before the initiation of ISP.; (4) Child-Pugh grade C liver function, a Child-Pugh score of 3 for ascites, or the presence of overt hepatic encephalopathy; (5) incomplete outcome data or missing essential baseline factors for analysis.
References
Publications (0)
Data not yet available