Actively Recruiting
Phase II Study of CEND-1 with Gemcitabine and Nab-Paclitaxel Compared to Placebo for First Treatment of Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-09-04
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of CEND-1 combined with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel with a placebo. This study focuses on patients with locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma who have not received prior systemic therapy. The goal is to find out if adding CEND-1 improves treatment outcomes. Participants will be randomly assigned to one of two groups. One group receives CEND-1 along with nab-paclitaxel and gemcitabine, while the other group receives a placebo with nab-paclitaxel and gemcitabine. Treatments are given intravenously on days 1, 8, and 15 of each 28-day cycle. This treatment schedule continues as first-line therapy. During the study, participants will be monitored for tumor response and survival outcomes over approximately 36 months. Researchers will assess objective response rate, overall survival, progression-free survival, and disease control rate. Safety will be tracked from the start of treatment until 30 days after the last dose. Participants will undergo regular evaluations including scans and health assessments throughout the study period.
CONDITIONS
Brief Title
A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma
Research Team
J
Jianming Xu, M.D
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