Clinical trial · Interventional
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial
- 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 present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Portal Vein Tumor Invasion | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tumor Thrombus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab plus Bevacizumab | Drug | — | UNRESOLVED |
| I-125 Seeds Brachytherapy in PVTT | Procedure | — | UNRESOLVED |
| Transcatheter arterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
- description
- TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
- interventionNames
- Procedure: I-125 Seeds Brachytherapy in PVTT
- Procedure: Transcatheter arterial chemoembolization
- Drug: Atezolizumab plus Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- TACE and Atezolizumab/Bevacizumab (TACE-AB)
- description
- TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE. TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between18 and 75 years; * Has a diagnosis of HCC confirmed by radiology, histology, or cytology; * Type I PVTT or type II PVTT; * Child-Pugh class A; * Eastern Cooperative Group performance status (ECOG) score of 0-1; * No prior systemic therapy for HCC. * Adequate hematologic and end-organ function; * At least one measurable intrahepatic target lesion. Exclusion Criteria: * Diffuse HCC; * Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible; * Evidence of extrahepatic spread (EHS); * Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators; * Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \>CTCAE grade 3 within 4 weeks prior to randomization; * Active or history of autoimmune disease or immune deficiency; * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding; * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment; * Evidence of bleeding diathesis or significant coagulopathy; * Pregnant or breastfeeding females; * Significant cardiovascular disease; * Severe infection, such as active tuberculosis; * Serious medical comorbidities; * History of organ or cells transplantation; * History of other uncurable malignancies.
References
Publications (0)
Data not yet available