Clinical trials are indispensable to gain and amplify knowledge about the efficacy and tolerance of drugs. Legislation stipulates that new drugs have to be clinically tested. The clinical trial that we are presenting here has received a positive opinion of the responsible Ethics Committee(s) and has been approved by all concerned regulatory authorities – as required by law. This clinical trial will be conducted at several international study sites and shall include approximately 665 patients. The trial is initiated and organized by the sponsor, the Faculty of Medicine of the University of Magdeburg, Germany.
Participation in this trial is voluntary. You will only be included if you have given your written informed consent.
We are convinced that the diagnosis and the therapy of liver cancer can be improved. In the SORAMIC trial we want to compare new diagnostic methods and therapeutic approaches with today’s practices.
After inclusion into this trial, detailed data about the patients’ medical history will be collected together with data about the course of their liver cancer disease. In addition, there will be thorough medical examination (including blood tests and ECG) and a questionnaire to complete on patients’ current quality of life. Thereafter begins the diagnostic part of the trial.
Within the diagnostic part of the trial, the patients will undergo computed tomography (CT) of the abdomen and the chest as well as magnetic resonance imaging (MRI) of the abdomen.
One of these examinations (CT or MRI) would have been required for planning of your therapy in any case, even without participation in this trial. The second examination will be performed only if you are participating in this trial. Both examinations (CT and MRI) require the administration of a contrast agent into a vein (usually into a vein of the forearm).
Computed Tomography is today’s standard procedure for patients suffering from liver cancer. MRI is a modern and according to present knowledge, safe method. MRI allows obtaining images from the inside of the body without using x-rays or radioactivity.
This trial involves the application of the new MRI contrast agent Primovist®. Primovist® has been approved for diagnostic imaging in liver disease.
Within the diagnostic part of this study we want to assess the value of Primovist® for treatment decisions in patients with liver cancer as well as its value for detection of disease recurrence (recurrence of the tumour after treatment). Therefore Primovist®- MRI will be compared to CT.
In case you do not comply with the criteria for further treatment within the trial, your participation in the trial will stop after imaging is completed. In that case, your attending physician will propose to you a suitable, internationally recommended therapy approach. In the following, the study procedures are explained separately for patients with advanced liver cancer and patients with less advanced liver cancer.
Patients with advanced liver cancer:
All patients in this group will receive the drug Nexavar. They would also receive Nexavar treatment if they decided to not participate in this trial as it is clinical routine. One half of the patients in this group will receive supplementary therapy with SIR spheres before start of Nexavar treatment. SIR Spheres® are radioactive microspheres that are injected into the liver via the liver artery. These SIR spheres block primarily the tumor vessels and destroy the liver tumors by release of radiation. SIR Spheres® are licensed for the treatment of liver cancer. In this study arm the physicians want to assess if the combination of SIR spheres treatment with Nexavar achieves a beneficial therapeutic effect compared to Nexavar only. Chance (randomization) will decide which patients receive SIR spheres treatment in addition to Nexavar.
SIR spheres therapy typically consists of 3 sessions. During the first session the vascular system is examined in preparation of therapy, during the second session the first liver lobe is treated, and during the third session the second liver lobe is treated four to six weeks later. The third session will not be necessary if the disease is limited to one liver lobe.
After the start of the therapeutic part of the study patients will be followed-up in regular intervals. The interval between these follow-up visits will be determined individually by the attending physician.
Patients with less advanced liver cancer:
For all patients of this group the liver lesions are removed by means of heat using radiofrequency ablation (RFA). Subject to the number of liver lesions one or two therapy sessions will be required. After RFA, the success of the treatment is verified by means of ultrasound, CT or MRI; for all imaging methods the injection of a contrast agent is required. The RFA procedure within the study does not differ from clinical routine. Subsequent to RFA, one half of the patients will receive Nexavar®, and the other half will receive an ineffective substance (“placebo”, corresponding to today’s standards). Chance (randomization) will decide which patients receive Nexavar. Nexavar is currently not approved for treatment of less advanced liver cancer.
After inclusion into the group of patients suffering from less advanced liver cancer they will be followed-up at two-month intervals. The follow-up examinations for this trial end 24 months after inclusion of the last patient into the study that suffers from less advanced liver cancer. After conclusion of the study the patients will be treated by the attending physician according to internationally accepted guidelines.