Clinical Trials Logo
  1. Home
  2. Hepatocellular Carcinoma (HCC)
  3. NCT03236649

The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:
Comparison of Efficacy and Safety of Icaritin Versus Sorafenib in First-line Treatment of PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects: a Multicenter, Randomized, Opened Phase III Clinical Trial

Clinical Trial Summary

The primary efficacy index of this study is to compare the OS of the two groups.

Clinical Trial Description

Icaritin is a newly discovered small molecular compound which is high selective ERa36 modulators ,the preclinical PK&PD and toxicity studies showed it can inhibit the growth of HCC cancer cells both in vitro and in vivo, combining clinical data perhaps it will be a very promising new drug to treat hepatocellular carcinoma (HCC) by targeting this nongenomic pathway. Shenogen decided to further investigate the efficacy and safety of Icaritin and to explore potential gene targets for treating HCC. The results of phase I study showed Icaritin has good safety and tolerance. The biological availability of Icaritin after meal is high and the half-life is relatively short. The phase Ib study enrolled 28 subjects. Among the 18 HCC subjects, 12 subjects received treatment in the oral administration group with 600 mg once, twice per day, after meal 30 minutes, 6 subjects received treatment in the oral administration group with 800 mg once, twice per day, after meal 30 minutes. The results showed that in the 600mg group there are 12 HCC patients whose therapeutic efficacy is evaluable now, one case of PR (10%), 5 cases of SD (50%) and 4 cases of PD (40%) were observed.Safety data showed that totally 24 AEs are probably related to investigational drug. Among them, 19 AEs are grade I, 5 AEs are grade II, no grade III or above AE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03236649
Study type Interventional
Source Beijing Shenogen Biomedical Co., Ltd
Contact
Status Terminated
Phase Phase 3
Start date September 20, 2017
Completion date February 8, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03007212 - Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis Phase 4
Withdrawn NCT04044326 - The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors N/A
Recruiting NCT04687969 - Multimodal Machine Learning Characterization of Solid Tumors
Completed NCT02562755 - Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone Phase 3
Withdrawn NCT02406508 - Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC Phase 2
Completed NCT01972672 - The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma Phase 2
Completed NCT01247298 - A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma Phase 0
Completed NCT03735628 - An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors Phase 1
Completed NCT02188901 - Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study N/A
Active, not recruiting NCT04522908 - Dose Escalation Study of Cabozantinib for Advanced HCC Patients With Preserved Liver Function Phase 2
Terminated NCT01433016 - Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI Phase 2
Withdrawn NCT04465734 - A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC Phase 3
Recruiting NCT05057013 - HMBD-001 in Advanced HER3 Positive Solid Tumours Phase 1/Phase 2
Active, not recruiting NCT03753659 - IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC) Phase 2
Terminated NCT03144661 - An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies Phase 1
Not yet recruiting NCT01821482 - A Study of DC-CIK to Treat Hepatocellular Carcinoma Phase 2
Completed NCT03516071 - A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC Phase 2
Completed NCT01761266 - A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma Phase 3
Not yet recruiting NCT06345001 - A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer Phase 1
Completed NCT02794805 - Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis Phase 2