CStone Pharmaceuticals ((HK:2616)) announced an update on their ongoing clinical study.
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Study Overview: CStone Pharmaceuticals is conducting a Phase III study titled ‘A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)’. The study aims to evaluate the efficacy and safety of Nofazinlimab combined with lenvatinib versus a placebo combined with lenvatinib in patients with advanced hepatocellular carcinoma, who have not received prior systemic treatment and are ineligible for locoregional therapy.
Intervention/Treatment: The study tests two interventions: Nofazinlimab (CS1003) combined with lenvatinib, and a placebo combined with lenvatinib. Nofazinlimab is administered intravenously every 21 days, while lenvatinib is taken orally once daily. The purpose is to assess the effectiveness of Nofazinlimab in improving treatment outcomes for HCC patients.
Study Design: This is an interventional study with a randomized allocation and a parallel intervention model. It employs a quadruple masking approach, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded. The primary purpose of the study is treatment-focused.
Study Timeline: The study began on December 13, 2019, and is currently active but not recruiting participants. The most recent update was submitted on July 29, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might be available.
Market Implications: The progress of this study could significantly impact CStone Pharmaceuticals’ stock performance and investor sentiment, as successful results might enhance the company’s position in the oncology market. The study’s outcome could also influence competitive dynamics within the pharmaceutical industry, particularly in the treatment of hepatocellular carcinoma.
The study is ongoing, and further details are available on the ClinicalTrials portal.