Clinical trial · Interventional
Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma
Transarterial Chemoembolization Combined With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase II, Single-Arm 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)
This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth. All participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.
Conditions
Conditions (2)
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 |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab and atezolizumab | Drug | — | UNRESOLVED |
| Transarterial chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE + LDBev + Atezo
- description
- Participants in this single-arm study will receive a combination treatment consisting of transarterial chemoembolization (TACE) followed by systemic therapy with low-dose bevacizumab and atezolizumab. TACE will be performed as the locoregional therapy to control intrahepatic tumors, after which bevacizumab and atezolizumab will be administered to inhibit angiogenesis and enhance antitumor immune activity. All participants will be treated according to the study protocol to evaluate the safety and clinical activity of this integrated therapeutic approach for unresectable hepatocellular carcinoma.
- interventionNames
- Procedure: Transarterial chemoembolization (TACE)
- Drug: bevacizumab and atezolizumab
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
- Time from randomization to death from any cause.
Secondary outcomes (1)
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; * 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