Combining portal vein embolization and drug-eluting bead TACE for large liver cancer treatment
A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy
This study is testing if combining two procedures, one that blocks blood flow to the liver and another that delivers chemotherapy directly to tumors, can help people with large liver cancer feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05103007 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of combining portal vein embolization (PVE) and portal vein ligation (PVL) with drug-eluting bead transarterial chemoembolization (DEB-TACE) in patients with large, unresectable hepatocellular carcinoma. The study is multicenter and randomized, focusing on patients with significant tumors in the right lobe of the liver. The goal is to assess both short-term and long-term outcomes of this combined approach compared to standard treatments. By increasing the future liver remnant and controlling tumor progression, this method aims to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with large or giant hepatocellular carcinoma in the right lobe, with Child-Pugh liver function grade A and ECOG performance status of 0-1.
Not a fit: Patients with distant metastasis, significant liver cirrhosis, or those who have previously undergone hepatectomy or TACE may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with large, unresectable liver tumors.
How similar studies have performed: While the combination of PVE/PVL with DEB-TACE is a novel approach, similar studies have shown promise in improving outcomes for patients with liver cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver; * Child-Pugh liver function grade A, * ECOG PS 0-1 * If the tumor is resected with R0, the remaining liver volume is insufficient * ICG-15R \< 30% * No serious organic diseases of heart, lung, brain and other organs; * No history of other malignant tumors; * The patient's survival time is expected to be more than 3 months. Exclusion Criteria: * Pregnant and lactating women * History of organ transplant * Tumor thrombus with portal vein trunk or left branch involved; * distant metastasis; * Patients with obvious liver cirrhosis (Plt \< 100 × 10 \^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices); * Active bleeding caused by various causes; * Suffering from severe acute or chronic diseases or infectious diseases; * History of hepatectomy or TACE treatment.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Wan-guang Zhang — Tongji Hospital
- Study coordinator: Wan-guang Zhang, M.D.
- Email: wgzhang@tjh.tjmu.edu.cn
- Phone: +8613886195965
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.