NCT06641713 HAIC Compared With TACE in Huge Hepatocellular Carcinoma
| NCT ID | NCT06641713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 664 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 664 participants in total. It began in 2024-10-01 with a primary completion date of 2025-06-30.
⚠ 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 compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Clinical diagnosis of primary 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. Exclusion Criteria: 1. recurrent 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. Eastern Cooperative Group performance status (ECOG) score of ≥2; 7. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 8. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Contact & Investigator
Feng Duan, MD
STUDY DIRECTOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06641713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06641713 currently recruiting?
Yes, NCT06641713 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT06641713 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06641713 clinical trial?
NCT06641713 is sponsored by Sun Yat-sen University. The principal investigator is Feng Duan, MD at Chinese PLA General Hospital. The trial plans to enroll 664 participants.
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