“Correlation of Drug Sensitivity in Pancreatic Ductal Adenocarcinoma Models with Clinical Response: A Prospective Study Using RECIST 1.1 Criteria and

Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients [ Time Frame: From enrollment to end within 2 weeks ]

  1. Evaluation of the efficacy of neoadjuvant therapy in clinical response using the internationally recognized Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Stable Disease (SD) and Partial Response (PR) are considered indicators of chemotherapy sensitivity (good response), while Progressive Disease (PD) is considered indicative of chemotherapy resistance (poor response).

  2. Drug sensitivity testing results were assessed using standardized IC50 values. The standardized IC50 values were treated as the testing variables, while the clinical response to chemotherapy was designated as the state variable. The ROC curves for both variables were analyzed, and the area under the curve (AUC) was calculated to assess their correlation. To analyze the correlation between the drug testing results and clinical prognosis, linear regression analysis was performed to evaluate the correlation between standardized IC50 values and patients’ progression-free survival (PFS) values.

Study Population

The patients with clinically and pathologically confirmed pancreatic ductal adenocarcinoma are considered potential candidates for this study. Clinical physicians will comprehensively document the medical history, including only patients above 18 years of age. Individuals with other malignant tumors or severe diseases will be excluded. Patients who are unable to provide independent informed consent will not be included in this study. All patients in this study will undergo adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of localized pancreatic ductal adenocarcinoma.

Criteria

Inclusion Criteria:

  • More than 18 years old

  • Diagnosed as colorectal cancer with or without liver metastases before

  • Pathologically proven colorectal cancer after surgery

Exclusion Criteria:

  • History of other malignancies or serious medical conditions

  • Inability to provide independent informed consent

https://clin.larvol.com/trial-detail/NCT05955092