According to the World Health Organization, cancer is one of the leading causes of death in the world. Hepatocellular Carcinoma is the most common type of liver-related cancer. It usually occurs due to chronic liver damage, cirrhosis, and long-term hepatitis(B&C) infections. It is a rare form of cancer but aggressive and almost untreatable.
The median survival rates for HCC have been progressively improving in the last decade. Diagnosis and available treatments have not contributed to improved statistics. This type of cancer is usually only detected in the late stages and by then spread throughout a patient’s body. Following a diagnosis patient, more than 50% of patients live to only about 6 – 20 months and less than 10% survive in 5 years.
The most commonly available forms of treatment are the normal course of cancer treatments like Transplantation of the malignant tissue, Surgical Resection – during a resection partial or complete removal of the liver is done depending on the metastasis of the cancer cells, Transarterial chemoembolization is a palliative care treatment wherein the size of a tumour can be significantly reduced by minimally invasive chemotherapy, Transarterial Radioembolization – here a catheter filled with the radioactive isotope is inserted through a small incision placed within the small blood vessel that feeds the tumour and finally, Radiofrequency ablation – this treatment is usually chosen where a patient is unsuitable for surgery, a probe(thin needle) is inserted into the skin to the site of the tumour and ablated using heat generated from alternating current. There are also other methods of radical treatment available in the form of clinical trials.
A cancer clinical trial is a last resort for many especially, for those patients who suffer from aggressive end-stage diseases. We at Liverindia started a trial that encompasses a differential approach to the treatment of Hepatocellular Carcinoma.
BOLLTi is a combined effort of different techniques of medicine. Sequential partial liver transplantation is followed by a bone marrow infusion from the same living related donor and immunotherapy. This treatment is only applicable to patients whose cancer remains confined to the liver but is too widespread to be removed by surgery or treated by a liver transplant from a deceased donor.
The purpose of this combined treatment is to reduce the risk of relapse after a liver transplant The bone marrow infusion may reduce the risk of cancer relapse in two ways.
Our trial is structured so that the immunosuppressants help us in two ways. To conserve the transplant graft. And also helps the donor’s bone marrow which contains natural killer cells which can attack any cancer cells that remain after the liver transplant.
A medical trial is performed to test a new treatment approach, a new medicine, or a new medical device. It is usually split into multiple phases of action. The research involves a comprehensive study of the effectiveness and improvement of the existing methods.
Our trial involves using a multidisciplinary cancer treatment termed ‘transplant oncology’ which involves a fusion of techniques from multi-visceral transplant surgery, radical resectioning and surgical oncology with targeted immunotherapy.
There are certain guidelines for a patient to be included in the trial. They are:
A matching liver donor and recipient are subject to differential analysis to find mandatory any anomalies. If found fit with no underlying issues a partial liver transplant is performed. After six weeks of recovery and growth period for the liver. A partial bone marrow infusion is performed from the same donor. Besides, the patient will get autologous dendritic cell infusions for 6 months which encourages the production of lymphocytes(natural killer cells).
The primary objective of BOLLTi trial is to characterize the recurrence-free survival of patients for 1 year following a bone marrow transplantation among recipients of prior partial liver transplantation from the same donor.
The trial encompasses findings on other frontiers. Firstly, tumour characteristics are studied. Secondly, the trial also includes periodic monitoring of circulating tumour cell-free DNA (cfDNA) to correlate with tumour responses.
There are secondary objectives of the trial that include patients who reveal tolerance of the transplanted liver and are off immunosuppression for >6 months without biochemical evidence of liver rejection.
To know more about the BOLLTi trials please contact us at LiverIndia.