Hepatocellular Carcinoma With PVTT Clinical Trial
Official title:
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial
The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is still controversial, and there is no universally agreed protocol for its treatment. Transarterial chemoembolization (TACE) has become the most popular palliative treatment for patients with unresectable HCC, and it is no longer considered as a contraindication to HCC with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still offer a chance of cure. With advances in surgical techniques, it has become feasible to remove all gross tumors, including PVTT which has extended to the main portal vein, safely by surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT. The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE.
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent
cause of cancer death worldwide. Hepatic resection (HR) is the conventional "curative"
treatment for HCC. In both the European and the Unit States Proposed Guidelines for HCC, HR
is recommended only for patients with preserved liver function and with a single HCC lesion.
Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced
cirrhosis, only 10%-30% of HCCs are amenable to such a "curative" treatment at the time of
diagnosis. Transarterial chemoembolization (TACE) has become the most popular palliative
treatment for patients with unresectable HCC, and it is no longer considered as a
contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long term
outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT.
To improve on the results of treatment of HCC with PVTT, attempts have been made to perform
HR for these patients . HCC with PVTT remains a contraindication to liver transplantation
because of the high rate of tumor recurrence, and because of the severe shortage of donor
organs. HR remains the only therapeutic option that may still offer a chance of cure. With
advances in surgical techniques, it has become feasible to remove all gross tumors,
including PVTT which has extended to the main portal vein, safely by surgery. More HCC with
PVTT, which previously were considered as unresectable, have become resectable. Recent
studies have even shown favorable long-term survival outcomes of HR in well-selected cases
of HCC with PVTT. However, the survival outcomes of patients with HCC with PVTT treated with
HR or with TACE have not been properly compared.
This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat
patients with HCC with PVTT. The investigators also aimed to identify patient groups that
might benefit more from either treatment with HR or TACE.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06210334 -
HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)
|
Phase 2 |