This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.
Study Type
OBSERVATIONAL
Enrollment
332
The electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc.
Zhongda Hospital,
Nanjing, Jiangsu, China
RECRUITINGZhongda Hospital
Nanjing, Jiangsu, China
ACTIVE_NOT_RECRUITINGOverall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame: up to approximately 2 years
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1, mRECIST and iRECIST) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
Objective response rate(ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1, mRECIST and iRECIST.
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RECIST 1.1, mRECIST and iRECIST.
Time frame: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Time frame: up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.