Actively Recruiting
Phase II Study of SHR-A1811 Combination for HER2-Positive Advanced or Metastatic Biliary Tract Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-03-06
54
Participants Needed
2
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the SHR-A1811 combination in patients with HER2-positive locally advanced or metastatic biliary tract cancer. This open, multicenter Phase II clinical trial aims to assess the effectiveness and safety of this treatment combination in this specific patient group. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and focuses on an important cancer subtype with limited treatment options. Participants will receive the SHR-A1811 combination, which includes the drugs SHR-A1811, SHR-1316, and SHR-8068. The study does not use placebo or blinding, and all enrolled patients receive the experimental treatment. The trial runs from screening through completion over an average period of three years, during which the treatments impact on the cancer will be closely monitored. During the study, participants will undergo regular assessments to measure the objective response rate, duration of response, disease control rate, progression-free survival, overall survival, and any adverse events. These evaluations will involve clinical examinations and monitoring by investigators. The total participation time includes screening and follow-up over about three years to collect comprehensive safety and efficacy data.
CONDITIONS
Brief Title
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Research Team
T
Tingting Lei, BM
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