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RFA, Radioembolization · 1 trial · 1 indication
In patients in whom local ablation therapy is appropriate, to determine if the sorafenib in combination with radiofrequency ablation (RFA) prolongs the time-to-recurrence (TTR) in comparison with RFA + placebo.
In patients in whom RFA is NOT appropriate (palliative treatment group), to determine if the combination of yttrium-90 microspheres (SIRT) + sorafenib improves the overall survival (OS) in comparison to sorafenib alone. Interim analysis will be conducted after 60 and 180 deaths and a final analysis after 240 deaths.
To confirm in a 2-step procedure that Primovist®-enhanced MRI is non-inferior (first step) or superior (second step) compared with contrast-enhanced multislice CT for assignment of patients to a palliative vs. local ablation treatment strategy. The overall study is successful, if the primary objectives 1 OR 2 are met, AND Primovist-enhanced MRI is at least non-inferior to contrast-enhanced CT for treatment stratification.
| Arm | Type | Description |
|---|---|---|
| local ablation group | OTHER | Local ablation group: Potentially curative treatment of early HCC includes surgical resection and local ablation (RFA, PEI, BT). Recurrence rates after such approaches are reported to amount to 50% at 3 years and 70% at 5 years. Tumor recurrence may be either due to de novo development of new primary tumors or due to intrahepatic (unrecognized) metastases. Prevention of recurrence after local ablation is an important strategy to improve overall survival. So far, adjuvant chemoembolization and chemotherapy have not proven to be effective in preventing recurrences. There is, however, a strong rationale to assume that sorafenib will be of value in the adjuvant treatment of HCC as sorafenib has a dual mechanism of action (inhibition of tumor proliferation and antiangiogenesis) and has proven efficacy in HCC. |
| palliative treatment group | ACTIVE_COMPARATOR | Radioembolization has been reported to be effective in patients with unresectable HCC with preserved liver function from a number of trials. Successful downstaging of disease rendering patients eligible for potentially curative therapies, and even histologically confirmed complete responses of unresectable HCC, have repeatedly been reported providing the rationale to evaluate SIRT+sorafenib in comparison to sorafenib alone. The impact of cirrhosis as a concomitant disease in most patients with HCC is that it limits the ability of many patients to tolerate chemotherapy and is an independent cause of death in HCC patients. Thus, the historical difficulty in demonstrating an effect of therapy on survival in patients with advanced-stage, unresectable HCC (the majority). A new therapy that is effective in controlling hepatic disease, is less toxic than traditional chemotherapy, and improves the quality of life for patients in the advanced stages of HCC could represent an alternative. |
| Name | Type | Description |
|---|---|---|
| RFA | PROCEDURE | A max.of 2 percutaneous RFA sessions is permitted per patient with a max.of 2 liver lesions treated in each RFA session. Randomization to sorafenib or placebo is performed after completion of RFA. Percutaneous RFA is to be performed according to the manufacturer's instructions and following as far as possible routine procedures of the participating hospital. Typically, RFA will be performed under conscious sedation, general anesthesia is permitted. After local anesthesia of the site of puncture, the applicator is positioned in the center of the lesion using ultrasound-, CT- or MR-guidance. The success of ablation is to be controlled directly after RFA using ultrasound, contrast-enhanced CT, or MR imaging. If for any reason RFA is deemed incomplete within the immediate follow-up (up to 2 weeks after the initial ablation), RFA is to be repeated once (in this case, the total (max.) number of RFA sessions will be three). The study procedure guide will contain further instructions for RFA. |
| Radioembolization (SIRT) | PROCEDURE | One SIRT prescription consists of the pre-treatment assessment followed by one or 2 treatment sessions The aim of pre-treatment assessment is to ensure delivery of the microspheres to the target. Evaluation includes a determination of the arterial location and any consequent necessity for coil-embolization of the gastroduodenal artery, right gastric artery and any other accessory arteries to prevent inadvertent administration of microspheres into the gastrointestinal tract or pancreas. In addition, parasitic extrahepatic supply should be coil-embolized. Patients in whom the shunt fraction indicates potential exposure to the lung to an absorbed radiation dose of more than 30 Gy should be excluded from treatment with SIR-Spheres. Patients who are randomized to receive SIRT but who are not regarded as eligible for SIRT after the pre-treatment assessment will be switched to the sorafenib only group within the palliative treatment arm. |
Inclusion Criteria 1. Age: 18-85 years 2. Diagnosis of hepatocellular carcinoma 3. If primary diagnosis of HCC: diagnosis based on the following criteria: 1. cyto-histological criteria, OR 2. radiological criteria: Focal lesion \>1 cm with arterial hypervascularization in 2 coincident imagin...
RFA, Radioembolization is an investigational therapy being studied for the treatment of Hepatocellular Carcinoma, a type of liver cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The treatment is being evaluated in patients with inoperable liver cancer.
RFA, Radioembolization is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The company is conducting clinical research to evaluate the safety and efficacy of this treatment for Hepatocellular Carcinoma.
RFA, Radioembolization is currently in Phase 2 clinical development. It is an investigational therapy and has not yet received regulatory approval. The Phase 2 trial has been completed, and the treatment is being studied for use in patients with inoperable liver cancer.
RFA, Radioembolization has been studied in one completed clinical trial with the identifier NCT01126645. This Phase 2 trial, titled 'Sorafenib and Micro-therapy Guided by Primovist Enhanced MRI in Patients With Inoperable Liver Cancer,' enrolled 529 participants with Hepatocellular Carcinoma in Germany.
No, RFA, Radioembolization is not the same as Sorafenib. The clinical trial NCT01126645 evaluated the combination of Sorafenib and micro-therapy, which includes radioembolization, in patients with inoperable liver cancer. Sorafenib is a separate drug that was used alongside the radioembolization procedure in this study.