A randomized, open-label, multicenter Phase III clinical trial protocol for recurrent or metastatic pancreatic ductal adenocarcinoma. The document outlines the study design for 198 patients comparing a combination of Serplulimab, gemcitabine, nab-paclitaxel, and stereotactic body radiotherapy against standard chemotherapy. The protocol was authored by Xin Wang and is scheduled for completion in May 2026.
Use Cases
- Designing similar clinical trials based on the described radio-immuno-chemotherapy strategy.
- Analyzing trial endpoints based on the described primary (Overall Survival) and secondary (PFS, ORR, DCR) outcomes.
- Studying immune spatial interactions based on the exploratory cyclic multiplex tissue staining assays mentioned.
Strengths
- The protocol is detailed, specifying a sample size of 198 patients and precise drug dosages.
- It clearly defines primary and secondary endpoints, including safety assessment via NCI-CTCAE v5.0.
Limitations
- The dataset is a 15.3 KB DOCX file, indicating limited scope and no structured data.
- Column-level documentation is absent; field semantics must be inferred after download.
Provenance
- Source
- figshare
- Collection Method
- Prospective, randomized, open-label, multicenter Phase III study.
- Freshness
- Last updated 2026-05-13 04:41:32; freshness should be verified.