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.
Hematological system function: Absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; international normalized ratio less than 1.7 or prothrombin time prolongation not exceeding 4 seconds.
Liver function: Alanine aminotransferase/aspartate aminotransferase not exceeding 5 times the upper limit of normal; total bilirubin ≤ 210 μmol/L [≤ 2.38 mg/dL]; albumin ≥ 28 g/L.
Renal function: Serum creatinine not exceeding 1.5 times the upper limit of normal.
Malignant tumors other than BTC;
Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);
Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;
Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;
The target population of this project is patients diagnosed with unresectable biliary malignancies and treated with systemic chemotherapy combined with immunosuppressive agents.
Cohort
Retrospective
Systemic chemotherapy combined with immunotherapy
DrugThe 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.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
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.
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.
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.
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.
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Zhongda Hospital
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Third Affiliated Hospital of Soochow University
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
The First Affiliated Hospital, University of Science and Technology of China
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Yunnan Cancer Hospital
Collaborator
