Combination of neo-TACE-HAIC and surgery for high-risk liver cancer patients
Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial
This study is testing if a new combination treatment of chemo and surgery can help high-risk liver cancer patients live longer and have fewer chances of the cancer coming back compared to just surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04777942 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining neo-transarterial chemoembolization with hepatic artery infusion chemotherapy (neo-TACE-HAIC) alongside surgery for patients with high-risk hepatocellular carcinoma (HCC) classified as BCLC A stage. The study aims to determine if this combined approach can reduce recurrence rates and improve survival compared to surgery alone. Participants will be randomly assigned to receive either the combination treatment or surgery alone, with a focus on those who have specific high-risk factors. The trial is being conducted at Sun Yat-sen University Cancer Center in Guangzhou, Guangdong.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with resectable BCLC A stage hepatocellular carcinoma and high-recurrence risk factors.
Not a fit: Patients with unresectable HCC or those who have received prior anti-HCC therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrence and improve survival rates for patients with high-risk hepatocellular carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years; * BCLC A stage with high-recurrence risk factor; * Patients with resectable primary hepatocellular carcinoma; * Child-Pugh A or B (7 score) liver function; * The volume of residual liver more than 30% Exclusion Criteria: * • With unresectable HCC * Pregnant woman or sucking period; * With other malignant cancer; * Received anti-HCC therapy before this study
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yunfei Yuan — Sun Yat-sen University
- Study coordinator: Jiliang Qiu
- Email: qiujl@sysucc.org.cn
- Phone: 862087343114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.