Comparing surgery and locoregional therapy for liver cancer with portal vein thrombosis
To Compare the Survival Differences in Patients With HCC and Portal Vein Tumor Thrombosis Treated With Liver Resection-based Therapy Versus Locoregional-based Therapy: a Prospective Cohort Study
This study tests whether surgery or a different type of treatment is better for people with liver cancer that has spread to the portal vein.
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 | NCT06248528 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of surgical treatment versus locoregional therapy for patients with hepatocellular carcinoma (HCC) that has invaded the portal vein, known as portal vein thrombosis (PVTT). It aims to explore the differences in treatment outcomes based on Eastern and Western medical guidelines, which currently recommend different approaches. The study will include patients aged 18-75 with specific health criteria and will assess overall survival and recurrence rates following treatment. By comparing these two treatment modalities, the research seeks to identify the most effective strategy for managing advanced HCC with PVTT.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of HCC and PVTT, who meet specific health criteria.
Not a fit: Patients with a history of other malignancies, recurrent HCC, or significant liver complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved treatment strategies and outcomes for patients with advanced liver cancer.
How similar studies have performed: While there are differing treatment approaches for HCC with PVTT, this study aims to provide new insights, as the comparative effectiveness of these specific interventions has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-75 years * Pathological type is HCC, and with PVTT * No extrahepatic HCC * Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 and Child-Pugh grade A for the liver resection group * ECOG performing status of 0-2 and Child-Pugh grade A-B for the locoregional-based group * Adequate hematologic and organ function Exclusion Criteria: * Any history of other malignant tumors or recurrent HCC * Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * Any persistent serious liver resection or locoregional therapy-related complications * Esophageal and/or gastric variceal bleeding within 6 months * Inability or refusal to comply with the treatment and monitoring * Participation in other clinical trials
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: WanGuang Zhang
- 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.