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

NCT ID: NCT07319767

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2025-10-15

Brief 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. We 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). We 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. We will not contact participants or change their care.

On the scans done before treatment and before surgery, we will calculate tumor response using several methods (RECIST 1.1 and volume-based methods, including TDTP-RECIST). We will compare these imaging results with the "pathology response" seen in the removed tumor tissue (how much living cancer is left). We 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pancreatic ductal adenoma cohort

No interventions assigned to this group

Biliary tract cancer cohort

No interventions assigned to this group

Breast cancer cohort

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed malignancy of one of the following types: biliary tract cancer (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer), breast cancer, or pancreatic ductal adenocarcinoma

2. Age 18 to 80 years (inclusive), any sex

3. Received neoadjuvant or conversion therapy before surgery; no prior anti-cancer therapy before that course

4. Underwent tumor surgical resection or biopsy after completion of neoadjuvant/conversion therapy

5. Available baseline and preoperative imaging with the same modality (contrast-enhanced CT or MRI) at both time points for response evaluation

6. Complete postoperative pathology report and follow-up data available

Exclusion Criteria

1. History of another malignancy or concurrent multiple primary cancers

2. Missing imaging or inconsistent imaging evaluation across time points (e.g., absent scans or differing modalities that preclude paired assessment)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen University General Hospital

OTHER

Sponsor Role: collaborator

Tianjin Cancer Hospital Airport Hospital

UNKNOWN

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jia Fan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Countries

China

Other Identifiers

ZS-TDTP-RECIST

Identifier Type: -

Identifier Source: org_study_id