NCT06070636 bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
| NCT ID | NCT06070636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Liver Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2025-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-05-20 with a primary completion date of 2025-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 infiltrative hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of infiltrative HCC. 2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin 3. Age between 18 and 75 years; 4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm; 5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5). 6. Child-Pugh class A or B; 7. Eastern Cooperative Group performance status (ECOG) score of 0-2; 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. HCC with capsule; 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.
Contact & Investigator
Zhimei Hunag, MD
STUDY DIRECTOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06070636 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070636 currently recruiting?
Yes, NCT06070636 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT06070636 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06070636 clinical trial?
NCT06070636 is sponsored by Sun Yat-sen University. The principal investigator is Zhimei Hunag, MD at Sun Yat-sen University. The trial plans to enroll 30 participants.