NCT07319767

Comparing the TDTP-RECIST With RECIST 1.1 and Other Volumetric Evaluation Methods for Assessing the Therapeutic Efficacy of Irregular Malignant Tumors

A Study Comparing the TDTP-RECIST With RECIST 1.1 and Other Volumetric Evaluation Methods for Assessing the Therapeutic Efficacy of Irregular Malignant Tumors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

This study looks at better ways to measure how tumors respond to treatment before surgery. Today, doctors often use RECIST 1.1 (Response Evaluation Criteria in Solid Tumors), which measures the longest diameter across a tumor on an axial scan. This can be unreliable for tumors with irregular shapes. The investigator will compare a new, simple 3-dimensional method called TDTP-RECIST (Three-Dimensional Twelve-Point RECIST) with RECIST 1.1 and other volume-based methods to see which one matches best with what is found in the tumor after it is removed. This is a retrospective study at Zhongshan Hospital, Fudan University (Shanghai, China), Shenzhen University General Hospital (Shenzhen, China), and Tianjin Cancer Hospital Airport Hospital (Tianjin, China). The investigator will review past medical records and CT or MRI scans from adults (18-80 years) who had biliary tract cancer, breast ductal carcinoma, or pancreatic ductal adenocarcinoma. All included patients received neoadjuvant or "conversion" therapy (treatment given before surgery to shrink the tumor) and then had surgery between 2019 and 2024. The investigator will not contact participants or change their care. On the scans done before treatment and before surgery, the investigator will calculate tumor response using several methods (RECIST 1.1 and volume-based methods, including TDTP-RECIST). The investigator will compare these imaging results with the "pathology response" seen in the removed tumor tissue (how much living cancer is left). The investigator will also see how well the imaging methods relate to clear surgical margins (R0 resection, meaning no cancer at the cut edge), time without cancer coming back (recurrence-free survival), and overall survival. About 120 participants are expected. The analysis is planned from August to December 2025. There are no study visits, procedures, or treatments for participants, so risks are minimal. There is no direct benefit to participants. Findings may help doctors choose better tools to judge treatment response for irregular tumors in the future. All data will be de-identified. The hospital's ethics committee has approved this retrospective review and waived individual consent. Sponsor: Zhongshan Hospital, Fudan University. Location: Shanghai, China.

Conditions

• Breast Cancer
• Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
• Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)

Timeline

• Start date: 2024-05-14
• Primary completion: 2025-07-05
• Completion: 2025-10-15
• First posted: 2026-01-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: China