Advanced hepatocellular carcinoma now has a precise treatment plan

      In recent years, there have been many breakthroughs in the clinical research of systemic therapies for hepatocellular carcinoma, including targeted and immunotherapy. However, in international and domestic clinical practice of advanced hepatocellular carcinoma, there is currently no standard or best first-line treatment plan for patients with poor prognosis.  

      It is reported that the majority of hepatocellular carcinoma patients in China are diagnosed with liver cancer in the middle to late stage, and over 80% have a history of HBV infection. Relatively, some late stage patients have poor physical fitness and are often accompanied by multiple underlying diseases and prognostic risk factors, such as severe liver function damage, abnormal immune function, and generally have significant side effects and poor tolerance to existing first-line treatments. These patients have high bilirubin levels, low platelets, and poor liver function during clinical treatment. When using existing chemotherapy and targeted drug therapy, the prognosis is generally poor and there are high levels of toxic side effects (grade 3 and 4 adverse reactions). At present, in clinical practice in China, there is a situation where some doctors use traditional Chinese medicine preparations as alternative treatment drugs, but most of these drugs lack the support of high-quality, randomized controlled, and multi center clinical trial evidence.

      Recently, the original Chinese medicine icariin soft capsules were approved for sale, filling the gap in precision treatment for advanced hepatocellular carcinoma. The State Drug Administration recently officially approved the registration application for the listing of the innovative traditional Chinese medicine medicine, icariin (Akoladine) soft capsule. This medicine is an original new drug of traditional Chinese medicine developed by Beijing Shengnuoji Pharmaceutical Technology Co., Ltd. for 15 years. Sun Yan, a famous domestic tumor expert and academician of the CAE Member, and Professor Qin Shukui, Qinhuai Medical District, Eastern Warzone General Hospital, are the chief experts. Through randomized control, double-blind double simulation, and national multi center phase III clinical research on excellence. Clinical trial data shows that icariin (Acoradine) soft capsules are suitable for unresectable hepatocellular carcinoma that is not suitable for or patients who refuse standard treatment and have not received systemic treatment in the past. The patient's peripheral blood complex markers meet at least two of the following detection indicators: AFP ≥ 400ng/mL; TNF-α<2.5pg/mL； IFN-γ≥7.0pg/mL。

      It is reported that icariin (Acoradine) soft capsules are the first small molecule immunomodulatory agent from the traditional Chinese medicine Epimedium. As a small molecule immunomodulatory drug, it can significantly prolong the overall survival of late stage hepatocellular carcinoma enriched populations with heavy baseline and poor prognosis, while significantly improving their quality of life, and has obvious clinical safety advantages. Professor Qin Shukui pointed out that the research scheme of icariin (Akoladine) fully drew on the latest international clinical enrichment design guidelines and the successful experience of the published enrichment design (REACH2) clinical research, combined with the precise enrichment design of hepatitis B virus related clinical features and heterogeneous characteristic markers of patients with poor prognosis in China, which promoted the precise clinical research and treatment exploration of advanced hepatocellular carcinoma; The launch of icariin (Akoladine) soft capsule provides a new solution closer to Chinese patients with poor prognosis for patients with advanced hepatocellular carcinoma. At the same time, it also opens up a new direction for the inheritance, innovation and exploration of indigenous innovative drugs, especially traditional Chinese medicine.