Clinical trial · Interventional
bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma
NCT06061276CI-TRIAL-00080943recruitingN/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 blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Camrelizumab | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Immunotherapy | — | UNRESOLVED | — |
| Lenvatinib | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bTAE-HAIC | Procedure | — | UNRESOLVED |
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bTAE-HAIC combined with Lenvatinib and Camrelizumab
- description
- bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks.
- interventionNames
- Procedure: bTAE-HAIC
- Drug: Lenvatinib
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 6 months
- description
- ORR, as determined based on tumor response according to RECIST 1.1, is defined as
Secondary outcomes (1)
- measure
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, and the total tumor size ≥15 cm; 4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5). 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. 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 8. Prothrombin time ≤18s or international normalized ratio \< 1.7. 9. 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 the main portal vein. 4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 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.