WGOG-PAN 006/ICSBR-2: Phase III Trial Protocol for Pancreatic Cancer Treatment

A 2026 clinical trial protocol document details a randomized, multicenter Phase III study comparing a novel radio-immuno-chemotherapy regimen to standard chemotherapy for recurrent or metastatic pancreatic ductal adenocarcinoma. The study, authored by Xin Wang, plans to enroll 198 patients naive to systemic therapy for advanced disease. The primary endpoint is Overall Survival, with secondary endpoints including progression-free survival and objective response rate.

Use Cases

• Analyzing trial design and statistical power based on the planned enrollment of 198 patients.
• Studying the combination of stereotactic body radiotherapy with checkpoint inhibitors and chemotherapy as described in the protocol.
• Benchmarking safety and efficacy outcomes against the NCI-CTCAE v5.0 criteria mentioned for safety assessment.
• Investigating immune spatial interactions using the cyclic multiplex tissue staining assays described as an exploratory endpoint.

Strengths

• The protocol is detailed, specifying exact drug doses (e.g., Serplulimab 300 mg IV, Q3W) and radiotherapy parameters (33–50 Gy/5 fractions).
• Clear primary and secondary endpoints are defined, including Overall Survival, progression-free survival, and Objective Response Rate.
• The document is licensed under CC-BY-4.0, allowing for broad reuse and sharing.

Limitations

• The dataset is a 16.6 KB DOCX file, indicating it is a small document, not a structured data table with patient records.
• Column-level documentation is absent; field semantics must be inferred from the textual description after download.
• Row count is unknown, which may limit suitability assessment for quantitative analysis.

Provenance

Source

figshare

Collection Method

Prospective, randomized, open-label, multicenter Phase III clinical trial protocol.

Freshness

Last updated 2026-05-13 04:41:37; freshness should be verified as it is a future date.