Impact of Transarterial Chemoinfusion on Survival in Liver Cancer Patients
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
This study is testing if a new treatment called transarterial chemoinfusion can help liver cancer patients live longer after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03368651 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of neo-adjuvant transarterial chemoinfusion (TAI) in improving survival rates for patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) who are undergoing hepatectomy. The study is a Phase 3, randomized, controlled trial that compares survival outcomes between patients receiving TAI and those who do not. Eligible participants must meet specific criteria related to their age, health status, and tumor characteristics. The trial is conducted at the Cancer Center of Sun Yat-sen University in Guangzhou, Guangdong.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diagnosed hepatocellular carcinoma and portal vein tumor thrombosis who are eligible for surgery.
Not a fit: Patients with distant metastasis, previous malignancies, or those unable to tolerate TAI or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced liver cancer.
How similar studies have performed: While the specific approach of neo-adjuvant TAI is being evaluated in this trial, similar interventions have shown promise in improving outcomes for liver cancer patients in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * older than 18 years old and younger than 75 years; * ECOG PS≤1; * proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * not previous treated for tumor; * estimated tumor and tumor thrombosis could be removed en bloc in operation; * no distant metastasis; * the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; * sign up consent; Exclusion Criteria: * cannot tolerate TAI or surgery; * distant metastasis exits; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of HIV infection; * known history of drug or alcohol abuse; * have GI hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy;
Where this trial is running
Guangzhou, Guangdong
- Cancer Center of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shaohua Li, MD
- Email: lishaoh@sysucc.org.cn
- Phone: +8615088064187
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.