Spots Global Cancer Trial Database for The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects
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Trial Identification
Brief Title: The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects
Official Title: Comparison of Efficacy and Safety of Icaritin Versus Cinobufotalin in First-line Treatment of Advanced Hepatocellular Carcinoma Subjects: a Multicenter, Randomized, Double-blind, Double-dummy Phase III Clinical Trial
Study ID: NCT03236636
Study Description
Brief Summary: The enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.
Detailed Description: The basis of enrichment design adjustment ： The latest published literature shows that the heterogeneity and immune tolerance of patients with hepatitis B virus (HBV) - related HCC are significantly correlated with a number of cytokines, including helper T cell subgroup 1 / 2 (Th1 / Th2) related factors. Moreover, the accumulated data show that the immunomodulatory effect of flavonoids including Icaritin is related to Th1 / Th2 factors. At the same time, the recent REACH2 study published in Lancet Oncology has successfully used serum alpha fetoprotein (AFP≥400) to enrich patients with advanced HCC. Based on the updated published data and our phase II clinical trial data, considering that the ongoing clinical trials are still in a blind state and no statistical analysis has been conducted, with consulting of clinical experts, regulatory agency advice, the protocol was amended and approved into adaptive enrichment design. Before unblended and SAP, the amendment protocol was prospectively pre-defined including sample size, patient population (CBS score positive), and event number for interim and final analysis. combined with the latest FDA clinical trial enrichment design guidelines (2019), several experts recommended to use the composite biomarkers, including IFN-γ , TNF - α and AFP, which may demonstrate the clinical advantages of the immunomodulation therapy with Icaritin for HBV-related advanced HCC patients in China with poor prognosis, but currently lack of treatment options. Definition of enriched HBV-related advanced HCC patient: Patient with serum composite biomarker score (CBS)≥2 Enrichment design amendment: Based on our previous phase II data of Icaritin collected from HBV-related advanced HCC patients and the related literature, we assume that the mOS of the enriched population (CBS≥2) is 420 days (14 months) in the experimental group and 240 days (8 months) in the HUACHASHU control group; the HR of the experimental group relative to the control group is 0.57. A total of 106 target death events and 130 evaluable subjects were required for the enrichment. Once the amendment protocol be effective, the enriched and non-enriched patients will be continuously randomized into the experimental and the control arms accordingly (1:1). When the number of enrolled cases reaches 280, or 60% of events (64) of 106 deaths has been observed in the enriched population, interim analysis will be performed.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Beijing Hospital, Beijing, Beijing, China
General Hospital of Chinese Armed Police Forces, Beijing, Beijing, China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing, China
Peking University Cancer Hospital, Beijing, Beijing, China
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing, China
The First People's Hospital of Foshan, Foshan, Guangdong, China
Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Haikou People's Hospital, Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Eastern Theater General Hospital,QinHuai District Medical Area, Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu, China
First Hospital of Jilin University, Changchun, Jilin, China
The Sixth People's Hospital in Shenyang, Shenyang, Liaoning, China
Chifeng Municipal Hospital, Chifeng, Neimenggu, China
Jinan Central Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China
The Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, China
Nanfang Hospital of Southern Medical University, Guangzhou, , China
Contact Details
Name: Yan Sun, MD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Shukui Qin
Affiliation: NanJing PLA 81 Hospital
Role: PRINCIPAL_INVESTIGATOR
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