Clinical trial · Interventional
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study
NCT06609863CI-TRIAL-00083240recruitingN/AClinicalTrials.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 study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Atezolizumab | — | UNRESOLVED | — |
| Bevacizumab | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dTACE-HAIC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dTACE-HAIC plus Bevacizumab and Atezolizumab
- description
- dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres was used (100-300um, 300-500um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 200 mg intravenously every 2 weeks.
- interventionNames
- Procedure: dTACE-HAIC
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 12 months
- description
- ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of HCC. 2. Age between 18 and 75 years; 3. The maximum tumor size ≥10 cm; 4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III 5. limited metastases (≤5). 6. Child-Pugh class A or B; 7. Eastern Cooperative Group performance status (ECOG) score of 0-1; 8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 9. Prothrombin time ≤18s or international normalized ratio \< 1.7. 10. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: 1. Diffuse HCC; 2. Extrahepatic metastasis \>5; 3. Obstructive PVTT involving mesenteric vena cava (PVTT IV). 4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding. 7. Eastern Cooperative Group performance status (ECOG) score of ≥2; 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.